Low-Dose Esketamine Combined with Propofol for Sedation in Elderly Patients Undergoing Bidirectional Endoscopy: A single-centre, double-blind, randomised, placebo-controlled trial
Abstract
<title>Abstract</title> <p> <bold>Background</bold> Sedation for same-visit bidirectional gastrointestinal endoscopy in elderly patients remains a major clinical challenge. Propofol monotherapy carries a prominent risk of respiratory and circulatory depression, particularly in geriatric patients with limited physiological reserve. Esketamine, the S-enantiomer of ketamine, exerts sympathomimetic effects that may offset propofol-induced hypotension and hypoxaemia. However, high-quality clinical evidence in this specific population is insufficient. This trial evaluated whether low-dose esketamine added to propofol reduces cardiopulmonary complications in elderly patients undergoing bidirectional endoscopy. <bold>Methods</bold> In this single-centre, double-blind, randomised, placebo-controlled trial, 316 elective patients aged 60–80 years with ASA physical status I–III were randomly assigned at a 1:1 ratio to receive either intravenous esketamine 0.15 mg/kg or normal saline placebo, followed by propofol 1 mg/kg for sedation induction. The dual primary outcomes were the incidence of intraoperative hypotension and hypoxaemia. Prespecified secondary outcomes included procedural efficiency and quality indicators. <bold>Results</bold> The overall incidence of intraoperative hypotension and hypoxaemia showed no significant intergroup differences. However, patients in the esketamine group maintained more stable intraoperative systolic blood pressure (SBP) and peripheral oxygen saturation (SPO₂) throughout the procedure. Esketamine also demonstrated superior procedural efficiency: shorter median induction time (120 s vs. 140 s; P < 0.001), 16.7% lower median propofol consumption (125 mg vs. 150 mg; P < 0.001), and 100% first-attempt gastroscope insertion success versus 94.9% with placebo (P = 0.007). Intraoperative bucking was halved (6.3% vs. 13.9%; P = 0.039). These gains were not offset by increased adverse events, including psychotomimetic effects, nausea and vomiting, dizziness, or cognitive impairment. Recovery times and patient satisfaction remained similarly high. <bold>Conclusions</bold> In conclusion, adjuvant low-dose esketamine combined with propofol did not reduce the incidence of intraoperative hypotension or hypoxemia in elderly patients undergoing same-visit bidirectional endoscopy. However, intraoperative SBP and SpO₂ were better preserved in patients receiving esketamine during the whole procedure. This regimen provided multiple clinical benefits including shortened induction time, higher first-pass gastroscopy insertion success rate, lower propofol dosage and reduced intraoperative bucking, without increasing overall adverse event risks. <bold>Trial registration</bold> Trial registration: This trial was prospectively registered on 26 March 2025 in the Chinese Clinical Trial Registry (registration number ChiCTR2500099643; https://www.chictr.org.cn/). </p>
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