Clinical TrialAnxiety DisordersEsketaminePlaceboNot yet recruiting

Effects of different doses of esketamine on postoperative delirium and postoperative cognitive function in elderly gastrointestinal tumor patients with preoperative anxiety

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.

Target Enrollment
Not specified
Study Type
Phase IV interventional
Design
Non-randomized

Study Arms & Interventions

Experimental

experimental

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;

Interventions

  • Esketamine

    Extracted from ChiCTR intervention description

Placebo

inactive

Interventions

  • Placebo

    Placebo/control arm

Participants

Ages
6080
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1: Aged 60-80 years.2: Diagnosed with gastrointestinal malignant tumor based on imaging and pathological examinations, and assessed as meeting surgical indications.3: Scheduled to undergo their first laparoscopic gastrointestinal tumor surgery.4: American Society of Anesthesiologists (ASA) physical status classification II-III.5: Amsterdam Preoperative Anxiety and Information Scale (APAIS) score >= 12.

Exclusion Criteria

  • Exclusion criteria: 1: Preoperative Montreal Cognitive Assessment (MoCA) score < 26.2: Pregnancy.3: Deafness or patients with language communication barriers.4: Patients at significant risk for increased intracranial pressure.5: Patients with renal insufficiency .6: Body Mass Index (BMI) >= 28 kg/m^2.7: Patients with poorly controlled or untreated hypertension (resting systolic/diastolic blood pressure exceeding 180/100 mmHg).8: Patients with psychiatric disorders; or those regularly using sedatives, antidepressants, or other drugs affecting metabolism.9: Patients with sinus bradycardia or severe atrioventricular block.10: Patients with untreated or poorly controlled hyperthyroidism.11: Patients with acute angle-closure glaucoma.12: Patients allergic to the active ingredient or any excipient of esketamine.13: Patients with hepatic insufficiency.

Study Details

Locations

China