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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04747379
Other study ID # 114966
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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