BIS Monitor Anesthesia for Neurocognitive Disorder
(POEGEA Trial)
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ciusss de L'Est de l'Île de Montréal
Disqualifiers: Dementia, Severe cognitive impairment, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The objective of the study is to investigate, in patients aged 70 years and over undergoing major non-cardiac surgery, the effect of electroencephalic (EEG)-guided anesthesia on postoperative neurocognitive disorders when controlling for intraoperative nociception, personalized blood pressure targets and using full information provided by the processed EEG monitor (including burst suppression ratio, density spectral array and raw EEG waveform).
This prospective, randomized, controlled trial will be conducted in a single Canadian university hospital. Patients aged 70 years and over, undergoing elective major non-cardiac surgery will be included. The administration of sevoflurane will be adjusted to maintain a BIS value between 40 and 60, a suppression Ratio at 0%, a direct EEG display without any suppression time and a spectrogram with most of the EEG wave frequency within the alpha, theta and delta frequencies in the EEG-guided group. In the control group sevoflurane will be administered to achieve an age-adjusted minimum alveolar concentration of \[0.8-1.2\]. A nociception monitor will guide intraoperative opioids' infusion and individual blood pressure targets will be personalized in both groups. The primary endpoint is the incidence of neurocognitive disorder (NCD) at postoperative day 1 evaluated by the Montréal Cognitive Assessment. Secondary endpoints include the incidence of postoperative neurocognitive disorder at different timepoints and the evaluation of cognitive trajectories among EEG-guided and control groups.
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 data supports the effectiveness of EEG-guided anesthesia for neurocognitive disorder?
Research suggests that EEG-guided anesthesia, which uses brain activity monitoring, can reduce the risk of patients becoming aware during surgery. However, there is not enough evidence to show it prevents neurocognitive disorders or improves long-term outcomes after surgery.
12345Is BIS Monitor Anesthesia safe for humans?
Research shows that using the BIS monitor during anesthesia can help reduce the amount of anesthesia needed and speed up recovery, which suggests it is generally safe. It also helps prevent anesthesia awareness, a serious complication, indicating its safety in monitoring anesthesia levels.
46789How is EEG-guided anesthesia different from other treatments for neurocognitive disorder?
EEG-guided anesthesia, using the Bispectral Index (BIS), is unique because it monitors brain activity to ensure the right depth of anesthesia, reducing the risk of awareness during surgery. This approach is different from standard methods that rely solely on anesthetic gas levels, offering a more precise way to manage anesthesia.
1491011Eligibility Criteria
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)
+1 more
Exclusion Criteria
I have a condition like dementia that severely affects my thinking.
I cannot communicate in French or English.
I need surgery urgently.
+2 more
Trial Timeline
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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
CIUSSS de l'Est de l'Île de MontréalMontréal, Canada
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Who Is Running the Clinical Trial?
Ciusss de L'Est de l'Île de MontréalLead Sponsor
MedtronicIndustry Sponsor
References
Auditory stimuli as a contributor to consciousness while under general anesthesia. [2013]The incidence of intraoperative awareness under general anesthesia approaches 1% in high-risk patients. Anesthesiologists commonly utilize processed electroencephalograms (EEG) in order to monitor "depth" of anesthesia, the most common of which is the Bispectral Index (BIS). The B-aware and B-Unaware trials, which were designed to test the efficacy of the BIS monitor, noted an auditory component in 16 of 17 confirmed cases of intraoperative awareness. Implicit auditory memory formation has been documented under general anesthesia. Small studies have documented a significant effect of noise on BIS scores during monitored anesthesia care.
Recovery of consciousness after thiopental or propofol. Bispectral index and isolated forearm technique. [2022]Currently, there exists no effective monitor that can predict the probability of a patient being conscious during general anesthesia. The electroencephalogram-derived bispectral index (BIS) is a promising new method to assess anesthetic adequacy. This study used the BIS to predict the probability of recovery of consciousness after a single bolus induction dose of propofol or thiopental.
American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on the Role of Neuromonitoring in Perioperative Outcomes: Electroencephalography. [2020]Electroencephalographic (EEG) monitoring to indicate brain state during anesthesia has become widely available. It remains unclear whether EEG-guided anesthesia influences perioperative outcomes. The sixth Perioperative Quality Initiative (POQI-6) brought together an international team of multidisciplinary experts from anesthesiology, biomedical engineering, neurology, and surgery to review the current literature and to develop consensus recommendations on the utility of EEG monitoring during anesthesia. We retrieved a total of 1023 articles addressing the use of EEG monitoring during anesthesia and conducted meta-analyses from 15 trials to determine the effect of EEG-guided anesthesia on the rate of unintentional awareness, postoperative delirium, neurocognitive disorder, and long-term mortality after surgery. After considering current evidence, the working group recommends that EEG monitoring should be considered as part of the vital organ monitors to guide anesthetic management. In addition, we encourage anesthesiologists to be knowledgeable in basic EEG interpretation, such as raw waveform, spectrogram, and processed indices, when using these devices. Current evidence suggests that EEG-guided anesthesia reduces the rate of awareness during total intravenous anesthesia and has similar efficacy in preventing awareness as compared with end-tidal anesthetic gas monitoring. There is, however, insufficient evidence to recommend the use of EEG monitoring for preventing postoperative delirium, neurocognitive disorder, or postoperative mortality.
Anesthesia awareness and the bispectral index. [2022]Awareness during anesthesia is a serious complication with potential long-term psychological consequences. Use of the bispectral index (BIS), developed from a processed electroencephalogram, has been reported to decrease the incidence of anesthesia awareness when the BIS value is maintained below 60. In this trial, we sought to determine whether a BIS-based protocol is better than a protocol based on a measurement of end-tidal anesthetic gas (ETAG) for decreasing anesthesia awareness in patients at high risk for this complication.
Bispectral Index (BIS) Monitoring and Postoperative Delirium in Elderly Patients Undergoing Surgery: A Systematic Review and Meta-Analysis With Trial Sequential Analysis. [2023]To examine the effect of bispectral index (BIS)-guided anesthesia on the incidence of postoperative delirium (POD) in elderly patients undergoing surgery.
Processed EEG and patient outcome. [2022]The era of research evaluating clinical outcomes associated with processed electroencephalogram (EEG) monitoring began with the first randomized trial of bispectral index monitoring (BIS) performed as part of the clearance process for approving routine clinical use of the BIS monitor by the United States Food and Drug Administration. Subsequent to this initial investigation, numerous other clinical investigations have demonstrated that the use of processed EEG monitors as an additional method of patient assessment and an aid to anaesthetic dosing can decrease anaesthetic usage and hasten recovery times. Because of the presumed association between anaesthetic effect and EEG changes, it is not surprising that the additional research has focused on the impact of processed EEG monitoring on postoperative outcomes and perioperative safety especially the prevention of intraoperative awareness.
Bispectral index monitoring allows faster emergence and improved recovery from propofol, alfentanil, and nitrous oxide anesthesia. BIS Utility Study Group. [2022]The bispectral index (BIS), a parameter derived from the electroencephalograph (EEG), has been shown to correlate with increasing sedation and loss of consciousness. This study determined whether addition of BIS monitoring to standard anesthetic practice results in improvements in the conduct of anesthesia or in patient outcomes.
Use of cerebral monitoring during anaesthesia: effect on recovery profile. [2019]This review article examines the effect of cerebral monitoring using an EEG-based device [i.e. bispectral index (BIS), patient state analyzer (PSA), auditory evoked potential (AEP), cerebral state index (CSI), or entropy] on titration of anaesthetic, analgesic and cardiovascular drugs during surgery. In addition, articles discussing the effects of these cerebral monitoring devices on recovery profiles following general anaesthesia, postoperative side effects, and anaesthetic costs are reviewed.
Does the use of electroencephalographic bispectral index or auditory evoked potential index monitoring facilitate recovery after desflurane anesthesia in the ambulatory setting? [2022]Analogous to the Bispectral Index (BIS) monitor, the auditory evoked potential monitor provides an electroencephalographic-derived index (AAI), which is alleged to correlate with the central nervous system depressant effects of anesthetic drugs. This clinical study was designed to test the hypothesis that intraoperative cerebral monitoring guided by either the BIS or the AAI value would facilitate recovery from general anesthesia compared with standard clinical monitoring practices alone in the ambulatory setting.
Impact of bispectral index monitoring on sedation and outcomes in critically ill adults: a case series. [2019]In situations in which clinical assessment of sedation level is compromised, such as deep sedation/analgesia with and without neuromuscular blockade (NMB), electroencephalogram-based monitoring may potentially assist in achieving balance between inadequate and excessive levels of sedation. To validate the bispectral index (BIS) for use in clinical practice, correlation and possible differences in outcome using clinical assessment versus clinical assessment augmented by electroencephalogram-based monitoring were determined. BIS monitoring was decisive in ICU care in 9 of 15 patients in this series. The most significant potential benefit was obtained in the subset of patients receiving NMB.
[Bispectral index (BIS)--a new ideology in solving an old problem]. [2006]A new method of electroencephalogram (EEG) processing is discussed: bispectral index (BIS), used for monitoring the depth of total anesthesia. The technology of BIS estimation is a principally novel approach to EEG processing, which can be denoted as an expert conclusion. EEG monitor Aspect A-100 (Aspect Medical System, USA) has been used for 3 years in the operation room during narcoses with barbiturates, propofol, midasolam, fentanyl, calypsol, isoflurane, and nitric oxide. BIS is a convenient and reliable method for evaluating the depth of total anesthesia with anesthetics with pronounced hypnotic effects at all stages of surgery. The disadvantages of the method are enumerated. The authors claim that monitors designed for expert evaluations hold good promise.