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).


Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2021
Historique:
received: 20 05 2021
accepted: 14 07 2021
entrez: 10 8 2021
pubmed: 11 8 2021
medline: 15 12 2021
Statut: epublish

Résumé

The number of elderly patients undergoing major surgery is rapidly increasing. They are particularly at risk of developing postoperative neurocognitive disorders (NCD). Earlier studies suggested that processed electroencephalographic (EEG) monitors may reduce the incidence of postoperative NCD. However, none of these studies controlled for intraoperative nociception levels or personalized blood pressure targets. Their results remain unclear if the reduction in the incidence of postoperative NCD relates to avoidance of any electroencephalographic pattern suggesting excessive anesthesia depth. The objective of this trial is to investigate-in patients ≥ 70 years old undergoing major non-cardiac surgery-the effect of EEG-guided anesthesia on postoperative NCD while controlling for intraoperative nociception, personalized blood pressure targets, and using detailed information provided by the 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 ≥ 70 years old undergoing elective major non-cardiac surgery will be included in the trial. The administration of sevoflurane will be adjusted to maintain a BIS index value between 40 and 60, to keep a Suppression Ratio (SR) at 0%, to keep 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]. In both groups, a nociception monitor will guide intraoperative opioid administration, individual blood pressure targets will be used, and cerebral oximetry used to tailor intraoperative hemodynamic management. The primary endpoint will be the incidence of NCD at postoperative day 1, as evaluated by the Montreal Cognitive Assessment (MoCA). Secondary endpoints will include the incidence of postoperative NCD at different time points and the evaluation of cognitive trajectories up to 90 days after surgery among EEG-guided and control groups. NCT04825847 on ClinicalTrials.gov.

Identifiants

pubmed: 34375362
doi: 10.1371/journal.pone.0255852
pii: PONE-D-21-16574
pmc: PMC8354438
doi:

Substances chimiques

Anesthetics, Inhalation 0
Sevoflurane 38LVP0K73A

Banques de données

ClinicalTrials.gov
['NCT04825847']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0255852

Déclaration de conflit d'intérêts

The authors have declared that no competing interests exist.

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Auteurs

Louis Morisson (L)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

Pascal Laferrière-Langlois (P)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.

François Martin Carrier (FM)

Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Department of Anesthesiology and Department of Medicine, Critical Care Division, Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal, Montréal, Québec, Canada.
Research Center of the CHUM (Centre Hospitalier de l'Université de Montréal), Université de Montréal, Montréal, Québec, Canada.

Gabrielle Pagé (G)

Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Research Center of the CHUM (Centre Hospitalier de l'Université de Montréal), Université de Montréal, Montréal, Québec, Canada.
Department of Psychology, Université de Montréal, Montréal, Québec, Canada.

Cédric Godbout (C)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Research Center of the CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

Louis-Philippe Fortier (LP)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Research Center of the CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

David Ogez (D)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Research Center of the CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

Geneviève Létourneau (G)

Research Center of the CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

Stéphanie Jarry (S)

Department of Anesthesiology, Montréal Heart Institute, Montréal, Québec, Canada.

André Denault (A)

Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Department of Anesthesiology, Montréal Heart Institute, Montréal, Québec, Canada.

Annik Fortier (A)

Department of Statistics, Montreal Health Innovations Coordinating Center (MHICC), Montréal, Québec, Canada.

Marie-Claude Guertin (MC)

Department of Statistics, Montreal Health Innovations Coordinating Center (MHICC), Montréal, Québec, Canada.

Olivier Verdonck (O)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Research Center of the CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

Philippe Richebé (P)

Department of Anesthesiology and Pain Medicine, Maisonneuve-Rosemont Hospital - CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Pain Medicine, Université de Montréal, Québec, Canada.
Research Center of the CIUSSS de L'Est de l'Ile de Montréal, Université de Montréal, Montréal, Québec, Canada.

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