This parallel, Phase 4 interventional trial in China (n=136) is investigating the effects of different doses of esketamine on postoperative delirium and postoperative cognitive function in elderly patients with gastrointestinal tumours who have preoperative anxiety. Participants aged 60 to 80 years, of both sexes, are being assigned to one of three esketamine dose groups (0.15 mg/kg, 0.25 mg/kg, or 0.5 mg/kg) or a placebo control group. The study is designed to compare whether lower or higher perioperative doses of esketamine influence neurocognitive recovery after surgery. The primary outcomes are postoperative delirium and postoperative cognitive function, assessed after the operation; the registry record does not specify the exact assessment timepoints. Secondary outcomes include anxiety, haemodynamic adverse events, intraoperative vital signs, postoperative pain, intraoperative propofol and remifentanil requirements, emergence agitation, and serum concentrations of interleukin-6, S100ß, and neuron-specific enolase. Sponsored by The Central Hospital of Wuhan, this trial reflects ongoing clinical research in China evaluating esketamine as a potential perioperative adjunct in older surgical patients at risk of neurocognitive complications.
Experimental Group: Esketamine 0.5 mg/kg Group (Group E0.5):Esketamine 0.5 mg/kg;Experimental Group: Esketamine 0.15 mg/kg Group (Group E0.15):Esketamine 0.15 mg/kg;Experimental Group: Esketamine 0.25 mg/kg Group (Group E0.25):Esketamine 0.25 mg/kg;Control group: Placebo group:Placebo;
Extracted from ChiCTR intervention description
Placebo/control arm