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

The investigators will conduct a 12,500-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: Depression; Quality of Life; Pain, Postoperative; Surgery; Anesthesia Morbidity; Anesthesia; Sleep Disorders, Circadian Rhythm; Anesthesia Awareness; Anesthesia Complication; Surgery-Complications
• Intervention / Treatment: Other: Anesthetic technique Propofol TIVA; Other: Anesthetic technique inhaled agent

• Study Type: Interventional
• Enrollment (Estimated): 12500
• 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
  • 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
  • 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
  • Missouri
    • Saint 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 York
    • New York, New York, United States, 10065
      • Not yet 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
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Not yet recruiting
      • UVA Health
      • Contact: Bhiken Naik, MD; Email: bin4n@uvahealth.org
      • Contact: Keita Ikeda, PhD; Email: ki2d@uvahealth.org
      • Principal Investigator: Bhiken Naik, 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 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
Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery	We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	baseline to day 1
Quality of Recovery-15 score on POD1 after minor inpatient surgery	We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	baseline to day 1
Quality of Recovery-15 score on POD1 after Outpatient surgery	We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	baseline to day 1
Incidence of unintended intraoperative awareness with recall on POD1 or POD30	Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 score on POD0 after major inpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD0 minor inpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD0 outpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD2 after major inpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD2 after minor inpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD2 after outpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD7 after major inpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD7 after minor inpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Quality of Recovery-15 score on POD7 after outpatient surgery	We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.	7 days
Incidence of delirium on POD0 after major inpatient surgery	Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.	1 day
Incidence of delirium on POD0 after minor surgery	Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery.	1 day
Incidence of delirium on POD1 after major inpatient	Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.	1 day
Incidence of delirium on POD1 after minor inpatient surgery	Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.	1 day
Incidence of delirium on POD1 after outpatient surgery	Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.	1 day
Days alive and at-home at POD30 after major inpatient surgery	The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.	30 days
Days alive and at-home at POD30 after minor inpatient surgery	The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.	30 days
EQ-5D-5L Quality of life on POD30 after major inpatient surgery	EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	30 days
EQ-5D-5L Quality of life on POD30 after minor inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	30 days
EQ-5D-5L Quality of life on POD30 after outpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	30 days
EQ-5D-5L Quality of life on POD90 after major inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	90 days
EQ-5D-5L Quality of life on POD90 after minor inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	90 days
EQ-5D-5L Quality of life on POD90 after outpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	90 days
EQ-5D-5L Quality of life on POD180 after major inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	180 days
EQ-5D-5L Quality of life on POD180 after minor inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	180 days
EQ-5D-5L Quality of life on POD180 after outpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	180 days
EQ-5D-5L Quality of life on POD365 after major inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	365 days
EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	365 days
EQ-5D-5L Quality of life on POD365 after out patient surgery	Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf	365 days
Bauer Questionnaire - Patient satisfaction with anesthesia at POD2	Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care: "very satisfied", "satisfied", "dissatisfied", or "very dissatisfied"	2 days
Respiratory failure on POD0	Respiratory failure on POD0	1 day
kidney injury on POD7	kidney injury on POD7	7 days
all-cause mortality at POD30	all-cause mortality at POD30	30 days
all-cause mortality at POD90	all-cause mortality at POD90	90 days
intraoperative hypotension	intraoperative hypotension	90 days
moderate to severe intraoperative patient movement	moderate to severe intraoperative patient movement	90 days
unplanned admission after outpatient surgery in an ambulatory setting	unplanned admission after outpatient surgery in an ambulatory setting	90 days
Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR	Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR	90 days
Incidence of malignant hyperthermia as reported in the EHR	Incidence of malignant hyperthermia as reported in the EHR	90 days
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have major inpatient surgery.	functional status	Baseline
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have minor inpatient surgery.	functional status	Baseline
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 for those scheduled to have outpatient surgery.	functional status	Baseline
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after outpatient surgery.	functional status	30 days
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after major inpatient surgery.	functional status	30 days
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after minor inpatient surgery.	functional status	30 days
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after minor inpatient surgery.	functional status	90 days
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after major inpatient surgery.	functional status	90 days
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 after outpatient surgery.	functional status	90 days

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 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): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Dyssomnias; Postoperative Complications; Pain; Neurologic Manifestations; Occupational Diseases; Intraoperative Complications; Chronobiology Disorders; Pain, Postoperative; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Intraoperative Awareness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics; Propofol
• Other Study ID Numbers: 202304082

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No