## Protocol Section
### Identification Module
**NCT ID:** NCT04747379

**Acronym:** PEERS

**Brief Title:** Psychological Effect of Explicit Recall After Sedation (PEERS)

**Official Title:** Psychological Effect of Explicit Recall After Sedation

#### Organization Study ID Info
**ID:** 114966
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-16

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2021-02-10
**Type:** ACTUAL
**Study First Submit Date:** 2020-10-27
**Study First Submit QC Date:** 2021-02-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lawson Health Research Institute

#### Responsible Party

**Investigator Affiliation:** Lawson Health Research Institute

**Investigator Full Name:** Jason Chui

**Investigator Title:** Anesthesiologist/Associate Professor, Western University, Department of Anesthesia and Perioperative Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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 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)

### Conditions Module

**Conditions:**

- Awareness, Anesthesia

- Post Traumatic Stress Disorder

- Depression

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Explicit recall will be assessed by Modified Brice Questionnaire

**Measure:** Explicit recall

**Time Frame:** Up to 6 hours after surgery

#### Secondary Outcomes

**Description:** 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.

**Measure:** Explicit Recall

**Time Frame:** Postoperative Day 1

**Description:** 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.

**Measure:** Sensation During Awareness

**Time Frame:** Postoperative Day 1

**Description:** 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.

**Measure:** Details of recall experience

**Time Frame:** Postoperative Day 1

**Description:** PCL-S Questionnaire

**Measure:** Post Traumatic Stress Disorder

**Time Frame:** Postoperative 3 Months

**Description:** PHQ-9 Questionnaire

**Measure:** Depression

**Time Frame:** Postoperative 3 Months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jason.chui@lhsc.on.ca

**Name:** Jason Chui, MD

**Phone:** 519-685-8500

**Phone Ext:** 34435

**Role:** CONTACT

**Contact 2:**

**Email:** LeeAnne.Fochesato@lhsc.on.ca

**Name:** LeeAnne Fochesato, MD

**Phone:** 519-663-3384

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Jason Chui, MBChB

- **Role:** CONTACT

***Contact 2:***

- **Name:** LeeAnne Fochesato, MSc

- **Role:** CONTACT

**Country:** Canada

**Facility:** London Health Science Centre

**State:** Ontario

**Status:** RECRUITING

**Zip:** N6A 5A5

#### Overall Officials

**Official 1:**

**Affiliation:** University of Western Ontario, Canada

**Name:** Jason Chui, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000007431

- Term: Intraoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Post Traumatic Stress Disorder

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: HIGH

- As Found: Traumatic Stress Disorder

- ID: M29299

- Name: Intraoperative Awareness

- Relevance: HIGH

- As Found: Awareness, Anesthesia

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10465

- Name: Intraoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058926

- Term: Intraoperative Awareness

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-24
