Psychological Effect of Explicit Recall After Sedation (PEERS)

NCT04747379 | Completed

• 1 other identifier: 114966
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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 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 determine the incidence of explicit recall under sedation/regional anaesthesia in adults, and to identify whether explicit recall experiences - or specific elements of those experiences (e.g. feeling pain and paralysis) - were associated with psychiatric sequelae. In this study, we will prospectively include 2500 patients who will be scheduled to have total hip and knee 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. 1.Enrollment/Surgical Preparatory Area (\~ 2 hours before surgery)
2. 2.Post Anesthesia Care Unit (assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission)
3. 3.Postoperative day one (in hospital)
4. 4.Postoperative 6 weeks (expected to be after discharge via telephone or in-person in clinic)

Conditions

Awareness, Anesthesia; Post Traumatic Stress Disorder; Depression

Keywords

recall; awareness; sedation; post-traumatic stress disorder; trauma; depression; suicide; anesthesia

Outcome Measures

Primary Outcomes (1)

• Explicit recall

  Explicit recall will be assessed by Modified Brice Questionnaire

  Assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission

Secondary Outcomes (5)

• Explicit Recall

  Postoperative Day 1

• Sensation During Awareness

  Postoperative Day 1

• Details of recall experience

  Postoperative Day 1

• Post Traumatic Stress Disorder

  Postoperative 6 weeks

• Depression

  Postoperative 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patient (\> or = 18 years old)
• Scheduled to have orthopedic surgery or joint replacement therapy under sedation/regional anesthesia
• Patient is able to communicate in English
• ASA I-IV

You may not qualify if:

• Unable to obtain informed consent
• Patient received General Anesthesia (GA) or conversion to GA during their surgical procedures
• 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)
• 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)
• Unable to follow up via phone or attend a postoperative follow-up visit at postoperative 6 weeks

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Science Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Intraoperative Awareness; Stress Disorders, Post-Traumatic; Depression; Wounds and Injuries; Suicide

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Study Officials

• Jason Chui, MD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist/Associate Professor, Western University, Department of Anesthesia and Perioperative Medicine

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: February 10, 2021
• Study Start: September 16, 2021
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

CA (1)