Actively Recruiting
Neurocognitive Disorders After Major Surgery in Elderly
Led by Ciusss de L'Est de l'Île de Montréal · Updated on 2024-07-17
314
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
C
Ciusss de L'Est de l'Île de Montréal
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Neurocognitive Disorders After Major Surgery in Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 70 years of age or older
- Scheduled for major gynecologic, abdominal, urologic, thoracic, or orthopedic surgery via laparoscopy or laparotomy under general anesthesia
- Expected anesthesia time of more than 60 minutes
- Assessed by internal medicine and/or anesthesiology at the preoperative clinic
You will not qualify if you...
- Known diagnosis of dementia or severe cognitive impairment from neurological, psychiatric, developmental, or medical conditions
- Emergency surgery
- Significant hearing or vision impairment preventing cognitive testing
- Allergy, intolerance, or medical condition preventing use of the study anesthesia protocol
- Inability to communicate in French or English
AI-Screening
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Trial Site Locations
Total: 1 location
1
CIUSSS de l'Est de l'Île de Montréal
Montreal, Quebec, Canada, H1T2M4
Actively Recruiting
Research Team
P
Philippe Richebé, MD, PHD
CONTACT
N
Nadia Godin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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