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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

Must not have

Known diagnosis of dementia or other neurological, psychiatric, developmental, or medical condition that resulted in documented severe cognitive impairment

Inability to communicate in French or English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery is expected to last over an hour under anesthesia.

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I am 70 years old or older.

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I had major surgery with general anesthesia recently.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like dementia that severely affects my thinking.

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I cannot communicate in French or English.

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I need surgery urgently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.

Secondary study objectives

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 study objectives

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.

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.

0 / 6Eligibility criteria met