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Behavioural Intervention

BIS Monitoring for Neurocognitive Disorders(POEGEA Trial)

CIUSSS de l'Est de l'Île de Montréal, Montréal, Canada
Targeting 2 different conditionsBIS monitor +1 moreN/ARecruitingLed by Philippe Richebé, MD, PhDResearch Sponsored by Ciusss de L'Est de l'Île de Montréal

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.

Eligible Conditions
  • Neurocognitive Disorder
  • Anesthesia

POEGEA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

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 more
Other 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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

POEGEA 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
64 Previous Clinical Trials
4,807 Total Patients Enrolled
MedtronicIndustry Sponsor
599 Previous Clinical Trials
829,157 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."

Answered by AI
~54 spots leftby May 2024