BIS Monitor Anesthesia for Neurocognitive Disorder

(POEGEA Trial)

Recruiting at 1 trial location

Overseen By Nadia Godin

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ciusss de L'Est de l'Île de Montréal

Disqualifiers: Dementia, Severe cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: Intraoperative

314 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using anesthesia during major surgeries to prevent memory and thinking problems afterward. It compares standard anesthesia to a method that uses special brain monitoring (EEG) to guide the anesthesia, known as EEG-guided anesthesia. The trial seeks participants aged 70 or older undergoing major surgeries, such as gynecologic or orthopedic procedures, expected to last over an hour. The goal is to determine if this new method can reduce memory issues shortly after surgery and over time. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for older adults.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that EEG-guided anesthesia is safe for patients undergoing major non-cardiac surgery?

Research has shown that EEG-guided anesthesia is generally safe for patients. One study found that patients who received EEG-guided anesthesia had a 1.4% chance of dying within thirty days, compared to a 2.3% chance in the group that received usual care, suggesting it might be safer. Other studies suggest that EEG guidance during anesthesia may reduce the risk of postoperative delirium, or confusion after surgery.

While these findings are encouraging, researchers continue to study the safety of EEG-guided anesthesia, especially in older patients. Overall, results so far indicate that this method is well-tolerated. Always consult a healthcare provider if there are concerns about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EEG-guided anesthesia for neurocognitive disorders because it uses real-time brain monitoring to tailor anesthesia levels. Unlike standard care, which relies on set dosages of anesthetics like sevoflurane, this method adjusts anesthesia based on brain activity, potentially reducing over-sedation and improving recovery. This approach promises more personalized anesthesia management, which could lead to fewer complications and a smoother recovery for patients with neurocognitive disorders.

What evidence suggests that EEG-guided anesthesia is effective for preventing postoperative neurocognitive disorders?

Research has shown that brain wave monitoring during anesthesia can reduce the risk of memory and thinking problems after surgery, known as postoperative neurocognitive disorder (NCD). In this trial, participants in the Electroencephalographic (EEG)-guided group will have their anesthesia directed by BIS monitoring, which studies have found decreases the likelihood of these issues. One study discovered that brain wave guidance resulted in fewer cases of confusion and better mental function post-surgery. Another analysis showed that this approach significantly reduced memory and thinking problems in patients. These findings suggest that brain wave monitoring during anesthesia could effectively protect brain health during and after surgery, especially for older adults. ^{2 6 7 8 9}

Who Is on the Research Team?

Philippe Richebé, MD, PhD

Principal Investigator

Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est de l'Ile de Montréal - Canada

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am 70 years old or older.

Seen for assessment by internal medicine and/or anesthesiology at the preoperative clinic (CIEPC)

Exclusion Criteria

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

I cannot communicate in French or English.

I need surgery urgently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo EEG-guided or standard care anesthesia during major non-cardiac surgery

Intraoperative

1 visit (in-person)

Postoperative Monitoring

Participants are assessed for neurocognitive disorders and other outcomes at multiple postoperative timepoints

90 days

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for long-term cognitive outcomes and quality of life

90 days

Follow-up assessments at days 15, 30, and 90

What Are the Treatments Tested in This Trial?

Interventions

• Electroencephalic (EEG)-guided anesthesia

Trial Overview 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.

How Is the Trial Designed?

Group I: Electroencephalographic (EEG)-guided group Active Control 1 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) group Active Control 1 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.

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Published Research Related to This Trial

The study involved 40 unpremedicated surgical patients, with 20 receiving thiopental and 20 receiving propofol, and it demonstrated that the bispectral index (BIS) can effectively predict the likelihood of recovery of consciousness after anesthesia.

A BIS score below 65 indicates less than a 5% chance of regaining consciousness within 50 seconds, providing a useful tool for anesthesiologists to assess patient awareness during general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of consciousness after thiopental or propofol. Bispectral index and isolated forearm technique. Flaishon, R., Windsor, A., Sigl, J., et al.[2022]

EEG monitoring during anesthesia can significantly reduce the rate of unintentional awareness in patients undergoing total intravenous anesthesia, making it a valuable tool for anesthetic management.

While EEG-guided anesthesia shows similar efficacy in preventing awareness compared to traditional monitoring methods, there is currently insufficient evidence to support its use for preventing postoperative delirium, neurocognitive disorders, or long-term mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on the Role of Neuromonitoring in Perioperative Outcomes: Electroencephalography. Chan, MTV., Hedrick, TL., Egan, TD., et al.[2020]

In a study involving 2000 patients, both BIS-guided and ETAG-guided anesthesia protocols resulted in the same low incidence of anesthesia awareness, with only two cases in each group, indicating that neither method significantly reduced the risk of this complication.

The BIS monitoring did not lead to lower administration of anesthetic gases compared to the ETAG method, suggesting that routine use of BIS monitoring may not be necessary in standard anesthesia practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthesia awareness and the bispectral index. Avidan, MS., Zhang, L., Burnside, BA., et al.[2022]

The bispectral index (BIS) is a novel EEG processing method that effectively monitors the depth of total anesthesia during surgeries, providing reliable evaluations across various anesthetics used over a 3-year period.

While BIS is convenient and reliable for assessing anesthesia depth, the authors also acknowledge some disadvantages of the method, suggesting that further improvements in expert evaluation monitors could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bispectral index (BIS)--a new ideology in solving an old problem]. Vinogradov, VL., Likhvantsev, VV., Subbotin, VV., et al.[2006]

Processed EEG monitoring, particularly using bispectral index (BIS), has been shown to reduce the amount of anesthesia needed during procedures, leading to faster recovery times for patients.

Research indicates that processed EEG monitoring can enhance perioperative safety by helping to prevent intraoperative awareness, which is a critical concern during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processed EEG and patient outcome. Monk, TG.[2022]

Electroencephalogram-based monitoring, specifically using the bispectral index (BIS), can significantly improve the assessment of sedation levels in critically ill patients, especially those receiving neuromuscular blockade (NMB).

In a study involving 15 ICU patients, BIS monitoring was crucial in guiding sedation management for 9 of them, highlighting its potential to prevent both inadequate and excessive sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of bispectral index monitoring on sedation and outcomes in critically ill adults: a case series. Arbour, R.[2019]

Cerebral monitoring using EEG-based devices, such as BIS and PSA, can improve the titration of anaesthetic and analgesic drugs during surgery, potentially leading to better patient outcomes.

The review also highlights that these monitoring devices may positively influence recovery profiles and reduce postoperative side effects, although the impact on anaesthetic costs requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cerebral monitoring during anaesthesia: effect on recovery profile. White, PF.[2019]

In a systematic review of 10 trials involving 3,891 elderly patients, BIS-guided anesthesia did not significantly reduce the incidence of postoperative delirium (POD) compared to standard care, indicating that it may not be effective for this specific outcome.

However, BIS-guided anesthesia was associated with a lower incidence of postoperative cognitive dysfunction (POCD) and improved recovery metrics, such as faster extubation and discharge times from the post-anesthesia care unit (PACU).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bispectral Index (BIS) Monitoring and Postoperative Delirium in Elderly Patients Undergoing Surgery: A Systematic Review and Meta-Analysis With Trial Sequential Analysis. Chew, WZ., Teoh, WY., Sivanesan, N., et al.[2023]

In a study of 60 outpatients undergoing gynecologic laparoscopic surgery, using auditory evoked potential (AAI) and Bispectral Index (BIS) monitoring allowed for better titration of desflurane, resulting in shorter awakening and discharge times compared to standard monitoring practices.

Patients in the BIS and AAI guided groups reported significantly higher quality of recovery scores upon discharge, indicating that these monitoring techniques enhance recovery outcomes after general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of electroencephalographic bispectral index or auditory evoked potential index monitoring facilitate recovery after desflurane anesthesia in the ambulatory setting? White, PF., Ma, H., Tang, J., et al.[2022]

In a study of 22 patients undergoing general anesthesia, the use of earplugs significantly lowered the Bispectral Index (BIS) scores, indicating a potential reduction in the risk of intraoperative awareness, which can occur in about 1% of high-risk patients.

The findings suggest that auditory stimuli can influence EEG readings during anesthesia, and using earplugs may be a simple and safe method to enhance patient safety by potentially reducing the incidence of awareness during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory stimuli as a contributor to consciousness while under general anesthesia. Thiele, RH., Knipper, E., Dunn, LK., et al.[2013]

Using bispectral index (BIS) monitoring during anesthesia led to a significant reduction in propofol infusion rates (from 134 to 116 microg x kg[-1] x min[-1]) and improved recovery times, with patients extubated sooner and more oriented upon arrival in the postanesthesia care unit (PACU).

The study involved 302 patients and showed that while BIS monitoring improved recovery metrics, it did not change the intraoperative course, suggesting that BIS can effectively guide propofol administration without affecting overall anesthesia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bispectral index monitoring allows faster emergence and improved recovery from propofol, alfentanil, and nitrous oxide anesthesia. BIS Utility Study Group. Gan, TJ., Glass, PS., Windsor, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12379316/

Effect of intraoperative Electroencephalogram-guided ... Intraoperative EEG-guided anesthesia—particularly using BIS monitoring—reduces POCD incidence and improves subacute cognitive outcomes in ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2819715

Electroencephalography-Guided Anesthesia and Delirium ... Thirty-day mortality occurred in 8 of 567 patients (1.4%) in the EEG-guided group and 13 of 573 (2.3%) in the usual care group. Conclusions and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091222000149

Delirium Processed electroencephalography-guided ... Processed EEG-guided anaesthesia significantly reduced the incidence of postoperative neurocognitive disorder. This adds support to the increasing evidence ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10557275/

Effect of raw electroencephalogram-guided anesthesia ... rEEG-guided anesthesia did not reduce the incidence of postoperative respiratory, circulatory, neurological and gastrointestinal complications.

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1638282/pdf

Effect of electroencephalogram-guided anesthesia on ... This meta- analysis incorporates the most recent trials to evaluate the effectiveness of EEG- guided anesthesia in reducing postoperative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6439616/

Effect of Electroencephalography-Guided Anesthetic ... To assess whether EEG-guided anesthetic administration decreases the incidence of postoperative delirium. Design, Setting, and Participants.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9405602/

Electroencephalogram Features of Perioperative ... We present a review of the application of multi-channel EEG monitoring to predict the incidence of PND in older patients.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0255852

A trial protocol The POEGEA trial (POncd Elderly GEneral ... Earlier studies have suggested that electroencephalography (EEG) guided anesthesia reduced the incidence of postoperative delirium and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0952818024003015

Overcoming age: Slow anesthesia induction may prevent ... Slow anesthesia induction may be a suitable approach for geriatric patients to preserve spectral composition patterns typically found in younger brains.