Psychological Effect of Explicit Recall After Sedation (PEERS) (PEERS)

Psychological Effect of Explicit Recall After Sedation

Awareness, or explicit recall, under sedation is often intended and expected by anesthesiologists and is assumed that does not associate with any sequelae. Thus, awareness under sedation is a common event and is estimated to occur in around one-quarter of patients in our population. However, two recent registry studies suggested some patients with awareness under sedation have comparable psychological sequelae to those patients with awareness during general anesthesia. As such, we plan to conduct a a single center, prospective cohort study to evaluate the incidence, experience and psychological consequence of awareness under sedation.

In this study, we will prospectively include 2500 patients who will be scheduled to have major joint replacement surgery under regional anesthesia and sedation at University Hospital, London Health Sciences Center.

All participants will be assessed at four separate time points including:

1. Enrollment/Surgical Preparatory Area (~ 2 hours before surgery)
2. Post Anesthesia Care Unit (or up to 6 hours after surgery)
3. Postoperative day one (in hospital)
4. Postoperative 3 months (expected to be after discharge via telephone)

Study Overview

• Status: Recruiting
• Conditions: Depression; Post Traumatic Stress Disorder; Awareness, Anesthesia

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Jason Chui, MD; Phone Number: 34435 519-685-8500; Email: jason.chui@lhsc.on.ca
• Study Contact Backup: Name: LeeAnne Fochesato, MD; Phone Number: 519-663-3384; Email: LeeAnne.Fochesato@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Science Centre
      • Contact: Jason Chui, MBChB
      • Contact: LeeAnne Fochesato, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients scheduled to undergo orthopedic or joint replacement surgeries under sedation/regional anesthesia at University Hospital located in London, Ontario, Canada.

Description

Inclusion Criteria:

1. Adult patient (>18 years old)
2. Scheduled to have orthopedic surgery or joint replacement therapy under sedation/regional anesthesia
3. Patient is able to communicate in English
4. ASA I-V

Exclusion Criteria:

1. Unable to obtain informed consent
2. Patient received General Anesthesia (GA) or conversion to GA during their surgical procedures
3. Unable to conduct the survey such as language barrier, overt psychiatric disorder thought to interfere with the reliability of the interview (e.g. dementia etc)
4. Patient who is expected to require mechanical ventilation at postoperative period (i.e. unable to perform surveys at Post-Anesthesia Care Unit (PACU) and postoperative day one)
5. Unable to follow up via phone or attend a postoperative follow-up visit at postoperative 3 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explicit recall	Explicit recall will be assessed by Modified Brice Questionnaire	Up to 6 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explicit Recall	Explicit recall will be assessed by Modified Brice Questionnaire The Michigan Awareness Classification is used to report the levels of sensation during awareness. 5 Levels of sensation are classified as auditory, tactile, pain, paralysis, or pain and paralysis. A designation of 'D' for distress is used for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or similar reports that indicated emotional distress during the explicit recall experience.	Postoperative Day 1
Sensation During Awareness	The Michigan Awareness Classification - Michigan Score The Michigan Awareness Classification is used to report the levels of sensation during awareness. 5 Levels of sensation are classified as auditory, tactile, pain, paralysis, or pain and paralysis. A designation of 'D' for distress is used for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or similar reports that indicated emotional distress during the explicit recall experience.	Postoperative Day 1
Details of recall experience	Light, smell, and other feelings The Michigan Awareness Classification is used to report the levels of sensation during awareness. 5 Levels of sensation are classified as auditory, tactile, pain, paralysis, or pain and paralysis. A designation of 'D' for distress is used for patient reports of fear, anxiety, suffocation, sense of doom, sense of impending death, or similar reports that indicated emotional distress during the explicit recall experience.	Postoperative Day 1
Post Traumatic Stress Disorder	PCL-S Questionnaire	Postoperative 3 Months
Depression	PHQ-9 Questionnaire	Postoperative 3 Months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Jason Chui, MD, University of Western Ontario, Canada

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Intraoperative Complications; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Intraoperative Awareness
• Other Study ID Numbers: 114966

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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.: Yes