Preoperative ketamine administration for prevention of postoperative neurocognitive disorders after major orthopedic surgery in elderly patients: A multicenter randomized blinded placebo-controlled trial - 04/07/24

Doi : 10.1016/j.accpm.2024.101387

Franck Verdonk ^a,⁎ , Pierre Lambert ^b,^{^{1
These authors contributed equally to this work.}}, Clément Gakuba ^c,^{^{1
These authors contributed equally to this work.}}, Anais Charles Nelson ^d, Thomas Lescot ^a, Fanny Garnier ^e, Jean-Michel Constantin ^f, Danielle Saurel ^f, Sigismond Lasocki ^g, Emmanuel Rineau ^g, Pierre Diemunsch ^h, Lucas Dreyfuss ^h, Benoît Tavernier ⁱ, Lucillia Bezu ^j, Julien Josserand ^k, Alexandre Mebazaa ^l, Marine Coroir ^l, Karine Nouette-Gaulain ^m, Gerard Macouillard ^m, Pauline Glasman ⁿ, Denis Lemesle ⁿ, Vincent Minville ^o, Philippe Cuvillon ^p, Brice Gaudilliere ^q, Christophe Quesnel ^r, Pierre Abdel-Ahad ^s, Tarek Sharshar ^t, Serge Molliex ^u,^{^{1
These authors contributed equally to this work.}}, Raphael Gaillard ^s,^{^{1
These authors contributed equally to this work.}}, Jean Mantz ^v,^{^{1
These authors contributed equally to this work.}}
^a Department of Anesthesiology and Intensive Care, Hôpital Saint-Antoine and Hôpital Tenon, Assistance Publique-Hôpitaux de Paris. Sorbonne Université, GRC 29, DMU DREAM, Assistance Publique-Hôpitaux de Paris, Paris, and UMRS_938, Centre de Recherche Saint-Antoine (CRSA), Sorbonne Université-Inserm, Paris, 75012, France
^b Department of Anaesthesiology and Critical Care Medicine, Hôpital Nord, Saint Etienne, France
^c Normandie Univ, UNICAEN, CHU de Caen, Service d’Anesthésie-Réanimation chirurgicale, UNICAEN, INSERM, U1237, PhIND “Physiopathology and Imaging of Neurological Disorders” and Institut Blood and Brain at Caen-Normandie, Cyceron, Caen, France
^d INSERM, Centre d’Investigation Clinique 1418 Épidémiologie Clinique, Paris, France and Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Paris, France
^e Department of Anesthesiology and Intensive Care, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France
^f Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
^g Department of Anesthesiology and Intensive Care, University Hospital of Angers, Angers, France
^h Department of Anesthesiology and Intensive Care, Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Strasbourg, France
ⁱ Department of Anesthesiology and Intensive Care Medicine, Lille University Hospital and Université de Lille, ULR 2694 – METRICS, Lille, France
^j Department of Anesthesiology, Gustave Roussy Cancer Campus, Villejuif, France and Department of Anesthesiology and Intensive Care, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France
^k Department of Anesthesiology, Foch Hospital, Suresnes, France
^l Department of Anesthesiology, Burn and Critical Care, University Hospitals Saint-Louis-Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France
^m CHU Bordeaux, Service d’Anesthésie Réanimation Pellegrin, Hôpital Pellegrin, Bordeaux, France
ⁿ Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Département d’Anesthésie Réanimation, Paris, France
^o Department of Anesthesiology and Intensive Care, Toulouse University Hospital, Toulouse, France
^p Department of Anaesthesiology and Pain Management, Centre Hospitalo-Universitaire (CHU) Carémeau, Nimes, France
^q Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USA
^r Department of Anesthesiology and Intensive Care, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France
^s GHU Paris Psychiatrie & Neurosciences, Hôpital Sainte-Anne, Service Hospitalo-Universitaire, Pôle Hospitalo-Universitaire Paris 15, Paris, France
^t Neuro-Anesthesiology and Intensive Care Medicine, Groupe Hospitalier Universitaire (GHU) Paris Psychiatrie et Neurosciences, Université de Paris, Paris, France
^u Department of Anaesthesiology and Critical Care Medicine, Hôpital Nord, and Sainbiose INSERM Unit 1059, Jean Monnet University, Saint Etienne, France
^v Department of Anesthesiology and Intensive Care, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France

^⁎Corresponding author.

Abstract

Background

Preventive anesthetic impact on the high rates of postoperative neurocognitive disorders in elderly patients is debated. The Prevention of postOperative Cognitive dysfunction by Ketamine (POCK) study aimed to assess the effect of ketamine on this condition.

Methods

This is a multicenter, randomized, double-blind, interventional study. Patients ≥60 years undergoing major orthopedic surgery were randomly assigned in a 1:1 ratio to receive preoperative ketamine 0.5 mg/kg as an intravenous bolus (n = 152) or placebo (n = 149) in random blocks stratified according to the study site, preoperative cognitive status and age. The primary outcome was the proportion of objective delayed neurocognitive recovery (dNR) defined as a decline of one or more neuropsychological assessment standard deviations on postoperative day 7. Secondary outcomes included a three-month incidence of objective postoperative neurocognitive disorder (POND), as well as delirium, anxiety, and symptoms of depression seven days and three months after surgery.

Results

Among 301 patients included, 292 (97%) completed the trial. Objective dNR occurred in 50 (38.8%) patients in the ketamine group and 54 (40.9%) patients in the placebo group (OR [95% CI] 0.92 [0.56; 1.51], p = 0.73) on postoperative day 7. Incidence of objective POND three months after surgery did not differ significantly between the two groups nor did incidence of delirium, anxiety, apathy, and fatigue. Symptoms of depression were less frequent in the ketamine group three months after surgery (OR [95% CI] 0.34 [0.13–0.86]).

Conclusions

A single preoperative bolus of intravenous ketamine does not prevent the occurrence of dNR or POND in elderly patients scheduled for major orthopedic surgery. (Clinicaltrials.gov NCT02892916).

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Keywords : Delayed neurocognitive recovery, Postoperative neurocognitive disorder, Ketamine, Frailty, Orthopaedic surgery

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Vol 43 - N° 4

Artículo 101387- août 2024 Regresar al número

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Preoperative ketamine administration for prevention of postoperative neurocognitive disorders after major orthopedic surgery in elderly patients: A multicenter randomized blinded placebo-controlled trial - 04/07/24

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