Effect of Esketamine on Postoperative Delirium in Patients Undergoing Cardiac Valve Replacement with Cardiopulmonary Bypass: A Randomized Controlled Trial
Abstract
BACKGROUND: The aim of this study was to investigate the effects of esketamine on the risk of postoperative delirium (POD) in adults undergoing on-pump cardiac valve surgery. METHODS: In this randomized, triple-blind, controlled trial, 116 adult patients with an American Society of Anesthesiologists (ASA) grade Ⅱ or Ⅲ and a New York Heart Association (NYHA) grade Ⅱ or Ⅲ who underwent cardiac valve surgery with cardiopulmonary bypass were included. Esketamine (0.25 mg/kg) or normal saline was administered intravenously before anesthesia induction. The primary outcome was POD, defined as a positive delirium assessment according to the 3-minute confusion assessment method (CAM) or the confusion assessment method for the intensive care unit (CAM-ICU) on a twice-daily basis for 7 days after surgery. Delirium duration and the delirium subtype were also recorded. The cognitive status of patients was measured according to the Mini-Mental State Examination at baseline, discharge, 30 days postoperatively and 3 months postoperatively. RESULTS: A total of 112 patients (mean age, 52 years; 53.6% female) were enrolled; 56 were assigned to receive esketamine, and 56 were assigned to receive placebo. POD occurred in 13 (23.2%) patients in the esketamine group and in 25 (44.6%) patients in the placebo group (relative risk [RR], 0.52, 95% confidence interval [CI], 0.28–0.91; P = .018). Thirteen patients (23.2%) in the esketamine group and 24 (42.9%) patients in the placebo group had multiple…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 116 participants or records.
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