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Neurocognitive Disorders After Major Surgery in Elderly

Neurocognitive Disorders | Anesthesia

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    70 and up

Participation 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.

Study Location

CIUSSS de l'Est de l'Île de Montréal
CIUSSS de l'Est de l'Île de Montréal
Montréal, Quebec
Canada

Contact Study Team

Backup Contact

Nadia NG Godin

[email protected]
5142523400
Primary Contact

Philippe PR Richebé, MD, PhD

[email protected]
5142523400
Study Sponsored By
Ciusss de L'Est de l'Île de Montréal
Participants Required
More Information
Study ID: NCT04825847