Psychological Effect of Explicit Recall After Sedation (PEERS)

Depression Clinical Trial

— PEERS  

Official title:

Psychological Effect of Explicit Recall After Sedation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747379
• Other study ID #: 114966
• Status: Recruiting
• Start date: September 16, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: Jason Chui, MD
• Phone: 519-685-8500
• Email: jason.chui[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Awareness, Anesthesia
• Depression
• Intraoperative Awareness
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Explicit recall	Explicit recall will be assessed by Modified Brice Questionnaire	Up to 6 hours after surgery
Secondary	Explicit Recall	Explicit recall will be assessed by Modified Brice Questionnaire; The Michigan Awareness Classi?cation is used to report the levels of sensation during awareness. 5 Levels of sensation are classi?ed 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
Secondary	Sensation During Awareness	The Michigan Awareness Classification - Michigan Score; The Michigan Awareness Classi?cation is used to report the levels of sensation during awareness. 5 Levels of sensation are classi?ed 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
Secondary	Details of recall experience	Light, smell, and other feelings; The Michigan Awareness Classi?cation is used to report the levels of sensation during awareness. 5 Levels of sensation are classi?ed 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
Secondary	Post Traumatic Stress Disorder	PCL-S Questionnaire	Postoperative 3 Months
Secondary	Depression	PHQ-9 Questionnaire	Postoperative 3 Months