Neurocognitive Disorders After Major Surgery in Elderly

NCT04825847 | Recruiting

• 1 other identifier: 2021-2611
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Neurocognitive Disorders

Keywords

Anesthesia; Processed EEG Monitor; Neurocognitive disorders; Major surgery; Burst Suppression; MoCA

Outcome Measures

Primary Outcomes (1)

• Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.

  The presence of postoperative neurocognitive disorder will be evaluated using the Montreal Cognitive Assessment The Montréal Cognitive Assessment range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 1 (primary endpoint)

  Postoperative day 1

Secondary Outcomes (16)

• Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result.

  Postoperative day 2

• Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result.

  Postoperative day 7

• Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result.

  Postoperative day 15

• Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result.

  Postoperative day 30

• Postoperative neurocognitive disorder day 90 (Yes/No); dichotomic result.

  Postoperative day 90

Other Outcomes (7)

• Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result; among prespecified subgroups of patients

  Postoperative day 1

• Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result; among prespecified subgroups of patients

  Postoperative day 2

• Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result; among prespecified subgroups of patients

  Postoperative day 7

Study Arms (2)

Electroencephalographic (EEG)-guided group

ACTIVE COMPARATOR

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.

Device: BIS monitor

Standard Care (SC) group

ACTIVE COMPARATOR

In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at \[0.8-1.2\] MAC.

Other: Control group

Interventions

BIS monitor DEVICE

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.

Electroencephalographic (EEG)-guided group

Control group OTHER

In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at \[0.8-1.2\] MAC.

Standard Care (SC) group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Medtronic: collaborator

Study Sites (1)

CIUSSS de l'Est de l'Île de Montréal

Montreal, Quebec, H1T2M4, Canada

RECRUITING

Related Publications (1)

• Morisson L, Laferriere-Langlois P, Carrier FM, Page G, Godbout C, Fortier LP, Ogez D, Letourneau G, Jarry S, Denault A, Fortier A, Guertin MC, Verdonck O, Richebe P. Effect of electroencephalography-guided anesthesia on neurocognitive disorders in elderly patients undergoing major non-cardiac surgery: A trial protocol The POEGEA trial (POncd Elderly GEneral Anesthesia). PLoS One. 2021 Aug 10;16(8):e0255852. doi: 10.1371/journal.pone.0255852. eCollection 2021.

  PMID: 34375362 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Philippe Richebé, MD, PhD

  Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est de l'Ile de Montréal - Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Richebé, MD, PHD

CONTACT

+1 (514) 252 3400; philippe.richebe@umontreal.ca

Nadia Godin

CONTACT

+1 (514) 252 3400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the anesthesiologist in charge in the operating room will be aware of treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Full professor, chair of research anesthesia and pain medicine

Model Details: Prospective monocentric randomized controlled trial

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: November 24, 2021
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

CA (1)