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Behavioural Intervention
BIS Monitor Anesthesia for Neurocognitive Disorder (POEGEA Trial)
N/A
Recruiting
Led By Philippe Richebé, MD, PhD
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Expected anesthesia time of more than 60 minutes
Patients 70 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
POEGEA Trial Summary
This trial will study whether using EEG-guided anesthesia can reduce the incidence of postoperative neurocognitive disorders in patients aged 70 years and over, compared to using age-adjusted minimum alveolar concentration.
Who is the study for?
This trial is for patients aged 70 or older who are undergoing major non-cardiac surgery and have an expected anesthesia time over 60 minutes. They must be able to communicate in English or French, without severe cognitive impairments from conditions like dementia, and not require emergency surgery.Check my eligibility
What is being tested?
The study tests if EEG-guided anesthesia can reduce postoperative neurocognitive disorders compared to standard care in elderly patients after major surgery. One group's anesthesia is adjusted using BIS monitor readings; the control group receives a standard dose of sevoflurane.See study design
What are the potential side effects?
While specific side effects aren't listed, general risks may include typical reactions to anesthesia such as nausea, confusion, muscle aches, itching or chills. The focus on neurocognitive effects suggests monitoring for memory issues or altered mental state.
POEGEA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery is expected to last over an hour under anesthesia.
Select...
I am 70 years old or older.
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I had major surgery with general anesthesia recently.
POEGEA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.
Secondary outcome measures
Awareness (Yes/no); dichotomic result
Cognitive Trajectories: Evolution of T-MoCA over time (score /22 without unit)
Postoperative delirium (Yes/No); dichotomic result
+13 moreOther outcome measures
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result; among prespecified subgroups of patients
Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result; among prespecified subgroups of patients
Neurocognitive Disorders
+4 morePOEGEA Trial Design
2Treatment groups
Active Control
Group I: Electroencephalographic (EEG)-guided groupActive Control1 Intervention
Information provided by the BIS (Medtronic, Canada) monitor will guide the volatile anesthetic administration in the EEG-guided group to maintain a BIS value between 40 and 60, a Suppression Ratio (SR; % of time with suppressed brain electrical activity) at 0% or the closest, a direct EEG display without any suppression time and a spectrogram (DSA or density spectral array) with most of the EEG wave frequency within the Alpha (8-12Hz), Theta (4-8Hz) and Delta (0.5-4Hz) frequencies.
Group II: Standard Care (SC) groupActive Control1 Intervention
In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC.
Find a Location
Who is running the clinical trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
70 Previous Clinical Trials
5,246 Total Patients Enrolled
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,351 Total Patients Enrolled
Philippe Richebé, MD, PhDPrincipal InvestigatorHôpital Maisonneuve-Rosemont - CIUSSS de l'Est de l'Ile de Montréal - Canada
3 Previous Clinical Trials
695 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people currently being recruited to participate in this clinical trial?
"The clinical trial, which was first advertised on November 24th 2021, is still seeking participants according to the latest information on clinicaltrials.gov. The post was last edited on March 10th, 2022."
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