Investigating EEG-guided anesthesia effects on cognitive disorders in elderly patients after major surgery
Effect of Electroencephalography-guided Anesthesia on Neurocognitive Disorders in Elderly Patients Undergoing Major Non-cardiac Surgery: a Randomized Clinical Trial
This study is testing if using EEG-guided anesthesia during major surgery can help older patients avoid cognitive problems afterwards compared to standard anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 314 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04825847 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of EEG-guided anesthesia on the incidence of neurocognitive disorders in patients aged 70 and older undergoing major non-cardiac surgery. The study will compare outcomes between an EEG-guided group, where anesthesia is tailored based on processed EEG data, and a control group receiving standard care. Key metrics include postoperative cognitive function assessed at various intervals, intraoperative medication consumption, and overall recovery outcomes. The trial will be conducted at a single university hospital in Canada, focusing on personalized anesthesia management to enhance patient safety and recovery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 years and older scheduled for elective major non-cardiac surgery lasting over one hour.
Not a fit: Patients with known dementia or severe cognitive impairment, emergency surgery needs, or significant communication barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of neurocognitive disorders in elderly patients after major surgery.
How similar studies have performed: While EEG-guided anesthesia is a relatively novel approach, preliminary studies suggest potential benefits in reducing postoperative cognitive issues, indicating a promising area of exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec
- CIUSSS de l'Est de l'Île de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Philippe Richebé, MD, PhD — Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est de l'Ile de Montréal - Canada
- Study coordinator: Philippe Richebé, MD, PHD
- Email: philippe.richebe@umontreal.ca
- Phone: +1 (514) 252 3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.