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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106981
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

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

Sponsors

The Central Hospital of Wuhan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

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 = 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.

Design outcomes

Primary

MeasureTime frame
postoperative delirium;postoperative cognitive function;

Secondary

MeasureTime frame
Anxiety;Hemodynamic adverse events;Intraoperative vital signs;postoperation pain;The dosage of propofol and remifentanil during the operation;emergence agitation;The concentrations of serum interleukin-6 (IL-6), central nervous system specific protein (S100ß), and neuron-specific enolase (NSE);

Countries

China

Contacts

Public ContactJin Zha

The Central Hospital of Wuhan

2357850902@qq.com+86 158 7108 3735

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026