Recruiting

EEG-Guided Anesthesia

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT04825847

Conditions

Anesthesia

Neurocognitive Disorders

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

BIS monitor

Control group

Study Details

Brief summary:

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.

Conditions

Anesthesia

Neurocognitive Disorders

Study ID

NCT04825847

Start date

Nov 24, 2021

Status verified date

Jul, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 70 years of age or older,
  • Major gynecologic, abdominal, urologic, thoracic or orthopedic surgery via laparoscopy or laparotomy under general anesthesia - with or without concomitant use of regional or neuraxial anesthesia -,
  • Expected anesthesia time of more than 60 minutes,
  • Seen for assessment by internal medicine and/or anesthesiology at the preoperative clinic (CIEPC)

Exclusion Criteria:

  • Known diagnosis of dementia or other neurological, psychiatric, developmental or medical condition that resulted in documented severe cognitive impairment,
  • Emergency surgery,
  • Significant auditory or visual impairment that precludes participation in cognitive testing,
  • Known allergy or intolerance or other medical condition that precludes the use of prescribed general anesthesia protocol for this study,
  • Inability to communicate in French or English.

Study Design

Enrollment

314 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Electroencephalographic (EEG)-guided group

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.

active comparator: Standard Care (SC) group

In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at \[0.8-1.2\] MAC.

Interventions

BIS monitor

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.

Control group

In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at \[0.8-1.2\] MAC.

Primary outcome measure

  • Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result. [ Time Frame: Postoperative day 1 ]

Central Contacts and Locations

Central contacts

Locations

CIUSSS de l'Est de l'Île de Montréal

Recruiting

Montréal, Quebec, Canada, H1T2M4

Contacts

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Jul 17, 2024

Last verified

Jul, 2024

Keywords

  • Anesthesia
  • Processed EEG Monitor
  • Neurocognitive disorders
  • Major surgery
  • Burst Suppression
  • MoCA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2024-07-17.