Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial (THRIVE)

The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Pain, Postoperative; Surgery; Anesthesia Morbidity; Anesthesia; Anesthesia Awareness; Anesthesia Complication; Surgery-Complications
• Intervention / Treatment: Other: Anesthetic technique Propofol TIVA; Other: Anesthetic technique inhaled agent

• Study Type: Interventional
• Enrollment (Estimated): 13000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Swisher; Phone Number: 314-286-1024; Email: goodl@wustl.edu
• Study Contact Backup: Name: Sherry McKinnon; Phone Number: 314-286-1024; Email: smckinnon@wustl.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences (UAMS)
      • Contact: Geoffrey Muller, MD; Email: gdmuller@uams.edu
      • Contact: Gwendolyn Cobbs Cobbs; Email: gfcobbs@uams.edu
      • Principal Investigator: Geoffrey Muller, MD
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Lee-lynn Chen, MD; Email: lee-lynn.chen@ucsf.edu
      • Contact: Neil Panchal; Email: Niel.Panchal2@ucsf.edu
      • Principal Investigator: Lee-lynn Chen, MD
      • Principal Investigator: Matthieu Legrand, MD
      • Principal Investigator: Jeremy Juang, MD
      • Principal Investigator: Jennifer Woodbury, MD
    • Stanford, California, United States, 94305
      • Not yet recruiting
      • Stanford University
      • Contact: David Drover, MD; Email: ddrover@stanford.edu
      • Contact: Samantha Gaston; Email: sgaston@stanford.edu
      • Principal Investigator: David Drover, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale School of Medicine
      • Contact: Jaime B Hyman, MD; Email: jaime.hyman@yale.edu
      • Contact: Andrew Shapiro; Email: andrew.shapiro@yale.edu
      • Principal Investigator: Jaime B Hyman, MD
      • Sub-Investigator: Robert B Schonberger, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Amit Bardia, MD; Email: abardia@mgb.org
      • Contact: Ariel Mueller, MA; Email: almueller@mgh.harvard.edu
      • Principal Investigator: Amit Bardia, MD
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's
      • Contact: Luigino Nascimben, MD; Email: lnascimben@bwh.harvard.edu
      • Contact: Sula Nasra; Email: snasra@bwh.harvard.edu
      • Principal Investigator: Luigino Nascimben, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Sub-Investigator: Sathish Kumar, MD
      • Contact: Allison Janda, MD; Email: ajanda@med.umich.edu
      • Contact: Rachel Shoemake; Email: rahersho@med.umich.edu
      • Principal Investigator: Sachin Kheterpal, MD
      • Principal Investigator: Allison Janda, MD
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Anoop Chhina, MD; Email: achhina1@hfhs.org
      • Contact: Katherine Nowak, PhD; Email: KNowak2@hfhs.org
      • Principal Investigator: Anoop Chhina, MD
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Laura Swisher; Email: goodl@wustl.edu
      • Contact: Sherry McKinnon, MS; Email: smckinnon@wustl.edu
      • Principal Investigator: Michael S Avidan, MBBch
      • Principal Investigator: Stephen Gregory, MD
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth Hitchcock Medical Center
      • Contact: Stacie Deiner, MD; Email: Stacie.G.Deiner@Hitchcock.org
      • Principal Investigator: Stacie Deiner, MD
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Kane O Pryor, MD; Email: kap9009@med.cornell.edu
      • Contact: Jay Sangwan; Email: jas4047@med.cornell.edu
      • Principal Investigator: Kane O Pryor, MD
    • New York, New York, United States, 10012
      • Recruiting
      • NYU Langone
      • Contact: Simon Tom, MD; Email: Simon.Tom@nyulangone.org
      • Contact: Lola Franco; Email: Lola.Franco@nyulangone.org
      • Principal Investigator: Simon Tom, MD
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University
      • Contact: Kam Ghadimi, MD; Email: kamrouz.Ghadimi@duke.edu
      • Contact: Kelly Rodden, BSN; Email: kelly.rodden@duke.edu
      • Principal Investigator: Kam Ghadimi, MD
    • Winston-Salem, North Carolina, United States, 27109
      • Recruiting
      • Wake Forest
      • Contact: Ashish Khanna, MD; Email: akhanna@wakehealth.edu
      • Principal Investigator: Ashish Khanna, MD
      • Contact: Amelia Eaton; Email: ameaton@wakehealth.edu
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Sciences University
      • Contact: Sarah Feller; Email: fellersa@ohsu.edu
      • Contact: Michael Aziz, MD; Email: azizm@ohsu.edu
      • Principal Investigator: Michael Aziz, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • University of Pennsylvania
      • Contact: Caoimhe Duffy, MD; Email: Caoimhe.Duffy@pennmedicine.upenn.edu
      • Contact: Karah Whatley; Email: karah.whatley@pennmedicine.upenn.edu
      • Principal Investigator: Caoimhe Duffy, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas - MD Anderson
      • Principal Investigator: Juan Cata, MD
      • Contact: Juan Cata, MD; Email: jcata@mdanderson.org
      • Contact: Paloma Aveni Strafile, MD; Email: PLAveni@mdanderson.org
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah - Medical
      • Contact: Ken Johnson, MD; Email: ken.b.johnson@hsc.utah.edu
      • Contact: Anne Mackey, MD; Email: u0840874@utah.edu
      • Principal Investigator: Ken Johnson, MD
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • UVA Health
      • Contact: Bhiken Naik, MD; Email: bin4n@uvahealth.org
      • Contact: Keita Ikeda, PhD; Email: ki2d@uvahealth.org
      • Principal Investigator: Bhiken Naik, MD
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Karen Domino, MD; Email: kdomino@uw.edu
      • Contact: Shawn Mincer; Email: smincer@uw.edu
      • Principal Investigator: Karen Domino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Each patient must meet all of the following criteria:

1. Aged 18 years or older
2. Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Exclusion Criteria

Patients will not be enrolled if any of the following criteria are met:

1. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
2. Pregnancy (based on patient report or positive test on the day of surgery)
3. Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
4. Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
5. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
6. Locally approved, written protocol mandating a particular anesthetic technique
7. History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
8. Planned postoperative intubation
9. Current incarceration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol total intravenous anesthesia (TIVA); No administration of inhaled agent.	Other: Anesthetic technique Propofol TIVA; Propofol TIVA no inhaled agent; Other Names: Propofol TIVA
Active Comparator: inhaled volatile general anesthesia (INVA); Must administer inhaled agent.	Other: Anesthetic technique inhaled agent; Must administer inhaled agent.; Other Names: Inhaled agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	Postoperative day 1
Incidence of definite intraoperative awareness with recall	The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.	Postoperative day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery	The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.	postoperative day 7
Days Alive and at Home at 30 days after major inpatient surgery	Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.	postoperative day 30
Days Alive and at Home at 30 days after minor inpatient surgery	Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.	postoperative day 30
Days Alive and at Home at 30 days after outpatient surgery	Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.	postoperative day 30
Incidence of delirium on postoperative day 0 after major inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.	postoperative day 0
Incidence of delirium on postoperative day 0 after minor inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.	postoperative day 0
Incidence of delirium on postoperative day 0 after outpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.	postoperative day 0
Incidence of delirium on postoperative day 1 after major inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.	postoperative day 1
Incidence of delirium on postoperative day 1 after minor inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.	postoperative day 1
Delirium Severity Score on postoperative day 0 after major inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.	postoperative day 0
Delirium Severity Score on postoperative day 0 after minor inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.	postoperative day 0
Delirium Severity Score on postoperative day 0 after outpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.	postoperative day 0
Delirium Severity Score on postoperative day 1 after major inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.	postoperative day 1
Delirium Severity Score on postoperative day 1 after minor inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.	postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.	postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.	postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.	postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.	postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery	The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.	postoperative day 1
Health-related quality-of-life on postoperative day 30 after major inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 30
Health-related quality-of-life on postoperative day 30 after minor inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 30
Health-related quality-of-life on postoperative day 30 after outpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 30
Health-related quality-of-life on postoperative day 90 after major inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 90
Health-related quality-of-life on postoperative day 90 after minor inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative 90 days
Health-related quality-of-life on postoperative day 90 after outpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 90
Health-related quality-of-life on postoperative day 180 after major inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 180
Health-related quality-of-life on postoperative day 180 after minor inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 180
Health-related quality-of-life on postoperative day 180 after outpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 180
Health-related quality-of-life on postoperative day 365 after major inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 365
Health-related quality-of-life on postoperative day 365 after minor inpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 365
Health-related quality-of-life on postoperative day 365 after outpatient surgery	EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	postoperative day 365
Functional status on postoperative day 30 after major inpatient surgery.	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.	postoperative day 30
Functional status on postoperative day 30, after minor inpatient surgery.	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.	postoperative day 30
Functional status on postoperative day 30, after outpatient surgery.	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.	postoperative day 30
Functional status on postoperative day 90 after major inpatient surgery.	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.	postoperative day 90
Functional status on postoperative day 90 after minor inpatient surgery.	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.	postoperative day 90
Functional status on postoperative day 90 after outpatient surgery.	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.	postoperative day 90
Patient satisfaction with anesthesia on postoperative day 2	The Bauer questionnaire is a patient self-reported survey assessing anesthesia-related discomfort and satisfaction with anesthesia care.	postoperative day 2
Respiratory Failure on postoperative day 0	Respiratory failure defined as unplanned postoperative intubation or reintubation or continued mechanical ventilation > 6 hours postoperatively. Reintubation due to reoperation is excluded.	postoperative day 0
Kidney Injury on postoperative day 7	Kidney Injury defined as a serum creatinine increase of 50% or 0.3 mg/dl from preoperative baseline	postoperative day 7
All-Cause Mortality at POD30	All-Cause Mortality at POD30	postoperative day 30
All-Cause Mortality at POD90	All-Cause Mortality at POD90	postoperative day 90
Intraoperative Hypotension (1)	Intraoperative Hypotension defined as cumulative duration of mean arterial pressure <55 mmHg for 20 minutes or greater.	postoperative day 0
Intraoperative Hypotension (2)	Intraoperative hypotension defined as cumulative duration of mean arterial pressure < 65 mmHg for 20 minutes or greater.	postoperative day 0
Moderate or Severe Intraoperative Patient Movement	Moderate or Severe Intraoperative Patient Movement is based on clinician report.	postoperative day 0
Unplanned Admission After Outpatient Surgery in an Ambulatory Setting	Hospital admission no later than 24 hours postoperatively after outpatient surgery in a free-standing ambulatory surgery center setting	postoperative days 0 and 1
Incidence of propofol-related infusion syndrome	Propofol related infusion syndrome, defined as acute refractory bradycardia in the presence of metabolic acidosis, and at least one of the following: rhabdomyolysis, acute kidney injury or hypertriglyceridemia, occurring after the start of propofol intraoperatively and within 6 hours postoperatively.	postoperative day 0
Incidence of malignant hyperthermia	Malignant hyperthermia, defined as unexplained muscle rigidity, tachycardia, hypercapnia, and rapidly increasing temperature leading to metabolic acidosis, rhabdomyolysis, disseminated intravascular coagulation, and ventricular arrhythmias, occurring after the start of an inhaled volatile agent intraoperatively and within 6 hours postoperatively.	postoperative day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.	Daily step count at baseline - number of steps per day	1 - 7 days prior to surgery
Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.	Daily step count at baseline - number of steps per day	1 - 7 days prior to surgery
Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.	Daily step count at baseline - number of steps per day	1 - 7 days prior to surgery
Daily step count as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day	7 - 10 days after surgery
Daily step count as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day	7 - 10 days after surgery
Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day	7 - 10 days after surgery
Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day	30 - 34 days after surgery
Daily step count as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day	30 - 34 days after surgery
Daily step count as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day	30 - 34 days after surgery
Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.	Daily standing hours: defined as standing hours per day	1 - 7 days prior to surgery
Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.	Daily standing hours: defined as standing hours per day	1 - 7 days prior to surgery
Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.	Daily standing hours: defined as standing hours per day	1 - 7 days prior to surgery
Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day	7 - 10 days after surgery
Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day	7 - 10 days after surgery
Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day	7 - 10 days after surgery
Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day	30 - 34 days after surgery
Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day	30 - 34 days after surgery
Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day	30 - 34 days after surgery
Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery.	Total sleep time defined as minutes of total sleep time per day	1 - 7 days prior to surgery
Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery.	Total sleep time defined as minutes of total sleep time per day	1 - 7 days prior to surgery
Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery.	Total sleep time defined as minutes of total sleep time per day	1 - 7 days prior to surgery
Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day	7 - 10 days after surgery
Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day	7 - 10 days after surgery
Total sleep time as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day	7 - 10 days after surgery
Total sleep time as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day	30 - 34 days after surgery
Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day	30 - 34 days after surgery
Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day	30 - 34 days after surgery
Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery.	Sleep onset latency: defined as minutes of sleep onset latency per day	1 - 7 days prior to surgery
Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery.	Sleep onset latency: defined as minutes of sleep onset latency per day	1 - 7 days prior to surgery
Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery.	Sleep onset latency: defined as minutes of sleep onset latency per day	1 - 7 days prior to surgery
Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day	7 - 10 days after surgery
Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day	7 - 10 days after surgery
Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day	7 - 10 days after surgery
Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day	30 - 34 days after surgery
Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day	30 - 34 days after surgery
Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day	30 - 34 days after surgery
Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.	Wake after sleep onset: defined as minutes of wake after sleep onset	1 - 7 days prior to surgery
Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.	Wake after sleep onset: defined as minutes of wake after sleep onset	1 - 7 days prior to surgery
Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.	Wake after sleep onset: defined as minutes of wake after sleep onset	1 - 7 days prior to surgery
Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset	7 - 10 days after surgery
Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset	7 - 10 days after surgery
Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset	7 - 10 days after surgery
Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset	30 - 34 days after surgery
Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset	30 - 34 days after surgery
Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset	30 - 34 days after surgery
Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery.	Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)	1 - 7 days prior to surgery
Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery.	Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)	1 - 7 days prior to surgery
Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery.	Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)	1 - 7 days prior to surgery
Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)	7 - 10 days after surgery
Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)	7 - 10 days after surgery
Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)	7 - 10 days after surgery
Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)	30 - 34 days after surgery
Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)	30 - 34 days after surgery
Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)	30 - 34 days after surgery
Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery.	Midpoint of sleep: defined as midpoint of sleep (time)	1 - 7 days prior to surgery
Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery.	Midpoint of sleep: defined as midpoint of sleep (time)	1 - 7 days prior to surgery
Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery.	Midpoint of sleep: defined as midpoint of sleep (time)	1 - 7 days prior to surgery
Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)	7 - 10 days after surgery
Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)	7 - 10 days after surgery
Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)	7 - 10 days after surgery
Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)	30 - 34 days after surgery
Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)	30 - 34 days after surgery
Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.	Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)	30 - 34 days after surgery

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Patient-Centered Outcomes Research Institute; University of Michigan
• Investigators: Principal Investigator: Sachin Kheterpal, MD, University of Michigan; Principal Investigator: Michael S Avidan, MBBCh, Washington University School of Medicine; Study Director: Allison Janda, MD, University of Michigan; Study Director: Mark Neuman, MD, University of Pennsylvania; Study Director: Bethany Pennington, PharmD, Washington University School of Medicine; Study Director: Douglas Colquhoun, MBChB, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Intraoperative Complications; Pain, Postoperative; Intraoperative Awareness; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Propofol
• Other Study ID Numbers: 202304082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per the contract with the funder PCORI, the THRIVE Data Sharing Plan will be consistent with PCORI's Policy for Data Management and Data Sharing, which calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. THRIVE will upload a deidentified dataset to the Patient-Centered Outcomes Data Repository (PCODR), which was created and is hosted by the Inter-University Consortium for Political and Social Research (ICPSR), a unit within the Institute for Social Research at the University of Michigan. The THRIVE study, as the Awardee, will enter into a Data Contributor Agreement (DCA) with ICPSR. The DCA governs the data deposition and establishes the Awardee's rights and obligations. The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
• IPD Sharing Time Frame: The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
• IPD Sharing Access Criteria: PCORI's access criteria and data sharing policy for third parties can be found here https://www.pcori.org/sites/default/files/PCORI-Policy-for-Data-Management-and-Data-Sharing.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No