Actively Recruiting

Phase Not Applicable
Age: 70Years +
All Genders
NCT04825847

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

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

CIUSSS de l'Est de l'Île de Montréal

Montreal, Quebec, Canada, H1T2M4

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here