Awareness, AnesthesiaPEERSNCT04747379
Psychological Effect of Explicit Recall After Sedation (PEERS)
An observational study of Awareness, Anesthesia and Post Traumatic Stress Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awareness, Anesthesia, Post Traumatic Stress Disorder, Depression
- How many people
- 2,500 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2021to 26 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read more
All participants will be assessed at four separate time points including:
- Enrollment/Surgical Preparatory Area (~ 2 hours before surgery)
- Post Anesthesia Care Unit (assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission)
- Postoperative day one (in hospital)
- Postoperative 6 weeks (expected to be after discharge via telephone or in-person in clinic)
Read the detailed description
Demographic and perioperative variables will be summarized. Descriptive statistics will be used to examine the incidence of awareness under sedation. We will further report the incidence of awareness with or without psychological sequalae, as well as the immediate and delayed awareness. We will also summarize the recall experience, initial emotional responses toward the event of awareness, as well as the patient satisfaction.
The psychological consequences will be defined and graded using the PHQ-9 (patient health questionnaire-9) and PCL-S (PTSD Checklist Stressor - S) questionnaires. The severity of harm using modified National Patient Safety Agency (NPSA) will also be described.
For the primary analysis, to assess the risk of explicit recall experience towards the development of PTSD and depression, we performed univariable logistic regression to assess whether explicit recall will be associated with either co-primary outcome. This will be followed by an assessment of individual element of recall experiences, such as auditory recall, feeling pressure, feeling pain and paralysis, etc. Multivariable logistic regression analysis will also performed to adjust for potential confounders
For the secondary analysis, we will further perform logistic regression analysis to assess the potential risk factors for explicit recall. The potential risk factors to fit into the models include: i) patient factors: obesity, obstructive sleep apnoea or any cardiopulmonary diseases that lead to sedation failure, history of psychiatric disease, ii) anestheteic factors such as the choice of sedatives, iii) patient expectation (assessed by NAP5 method), iv) duration and experiences of explicit recall (e.g. auditory, tactile or pain).
Additionally, we will assess patient expectations and communication between the patients and healthcare providers.
To assess the impact of surgery on the development of psychiatric symptoms, we will evaluate changes in the severity of depressive symptoms before and after surgery. We will also estimate the mental healthcare burden by determining the number of new psychiatric consultations potentially required.
P values <0.05 were accepted as statistically significant.
- Keywords
- recall, awareness, sedation, post-traumatic stress disorder, trauma, depression, suicide, anesthesia
- Medical subject headings
- Intraoperative Awareness, Stress Disorders, Post-Traumatic, Depression, Wounds and Injuries, Suicide
What is being measured
The primary outcome is the main question the study is designed to answer.
Explicit recall
Explicit recall will be assessed by Modified Brice Questionnaire
Measured: Assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Postoperative Day 1
Post Traumatic Stress Disorder
PCL-C Questionnaire
Measured: Postoperative 6 weeks
Depression
PHQ-9 Questionnaire
Measured: Postoperative 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start16 Sep 2021
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awareness, AnesthesiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Chui, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Jason Chui, MD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747379
- Sponsor's protocol ID
- 114966
- Acronym
- PEERS
- Status last verified
- Apr 2025
- First submitted
- 27 Oct 2020
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Effect of Explicit Recall After Sedation
- ClinicalTrials.gov ID
- NCT04747379
- Acronym / sponsor ID
- PEERS / 114966
- Keywords
- recall, awareness, sedation, post-traumatic stress disorder, trauma, depression, suicide, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Enrollment/Surgical Preparatory Area (~ 2 hours before surgery)
- Post Anesthesia Care Unit (assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission)
- Postoperative day one (in hospital)
- Postoperative 6 weeks (expected to be after discharge via telephone or in-person in clinic)
Detailed description
Demographic and perioperative variables will be summarized. Descriptive statistics will be used to examine the incidence of awareness under sedation. We will further report the incidence of awareness with or without psychological sequalae, as well as the immediate and delayed awareness. We will also summarize the recall experience, initial emotional responses toward the event of awareness, as well as the patient satisfaction.
The psychological consequences will be defined and graded using the PHQ-9 (patient health questionnaire-9) and PCL-S (PTSD Checklist Stressor - S) questionnaires. The severity of harm using modified National Patient Safety Agency (NPSA) will also be described.
For the primary analysis, to assess the risk of explicit recall experience towards the development of PTSD and depression, we performed univariable logistic regression to assess whether explicit recall will be associated with either co-primary outcome. This will be followed by an assessment of individual element of recall experiences, such as auditory recall, feeling pressure, feeling pain and paralysis, etc. Multivariable logistic regression analysis will also performed to adjust for potential confounders
For the secondary analysis, we will further perform logistic regression analysis to assess the potential risk factors for explicit recall. The potential risk factors to fit into the models include: i) patient factors: obesity, obstructive sleep apnoea or any cardiopulmonary diseases that lead to sedation failure, history of psychiatric disease, ii) anestheteic factors such as the choice of sedatives, iii) patient expectation (assessed by NAP5 method), iv) duration and experiences of explicit recall (e.g. auditory, tactile or pain).
Additionally, we will assess patient expectations and communication between the patients and healthcare providers.
To assess the impact of surgery on the development of psychiatric symptoms, we will evaluate changes in the severity of depressive symptoms before and after surgery. We will also estimate the mental healthcare burden by determining the number of new psychiatric consultations potentially required.
P values <0.05 were accepted as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Explicit recall
Time frame: Assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission
Explicit recall will be assessed by Modified Brice Questionnaire
5 secondary outcomes
Explicit Recall
Time frame: Postoperative Day 1
Sensation During Awareness
Time frame: Postoperative Day 1
Details of recall experience
Time frame: Postoperative Day 1
Post Traumatic Stress Disorder
Time frame: Postoperative 6 weeks
Depression
Time frame: Postoperative 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Chui, MD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Awareness, Anesthesia and Post Traumatic Stress Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit recall (time frame: Assessment will be conducted in PACU prior to discharge, within a maximum window of 6 hours from PACU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.