RecruitingNot ApplicableNCT04825847

Neurocognitive Disorders After Major Surgery in Elderly

Effect of Electroencephalography-guided Anesthesia on Neurocognitive Disorders in Elderly Patients Undergoing Major Non-cardiac Surgery: a Randomized Clinical Trial


Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrollment

314 participants

Start Date

Nov 24, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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Interventions

DEVICEBIS 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.

OTHERControl 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.


Locations(1)

CIUSSS de l'Est de l'Île de Montréal

Montreal, Quebec, Canada

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NCT04825847


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