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A multicenter randomized controlled clinical trial of the effect of esmketamine on postoperative delirium in elderly patients with gastrointestinal cancer

A multicenter randomized controlled clinical trial of the effect of esmketamine on postoperative delirium in elderly patients with gastrointestinal cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042765
Enrollment
Unknown
Registered
2021-01-27
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

gastrointestinal tumors in the elderly

Interventions

ES group (esketamine hydrochloride group):Anesthesia maintenance: 4~12mg/kg/h propofol was injected intravenously, and the pump speed of propofol was adjusted according to Narcotrend or BIS, and Narco
Group c (control group):Anesthesia maintenance: 4~12mg/kg/h propofol was injected intravenously, and the pump speed of propofol was adjusted according to Narcotrend or BIS, and Narcotrend 27~64 or BIS

Sponsors

Henan Province People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Aged 65~90 years, Han nationality, regardless of gender; 2) For patients undergoing laparoscopic gastrointestinal tumor surgery under general anesthesia, the operation duration is estimated to be 2 hours to 6 hours; 3) ASA grade I~III; 4) BMI is 18.5~29.9 kg/m2 [BMI= weight (Kg)/ height (m)2](2013 American "Adult Overweight and Obesity Management Guide"); 5) Volunteer to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with mental illness (including patients with delirium before operation) or taking antipsychotics (typical and atypical antipsychotics such as chlorpromazine, haloperidol, clozapine, risperidone, olanzapine and quetiapine); 2) Those with cognitive dysfunction before operation were judged by MMSE scale; 3) Serious impairment of hearing, vision and language system; 4) Any cerebrovascular accident occurred within 3 months, such as stroke and transient ischemic attack (TIA); 5) Severe abnormal liver and kidney function (severe abnormal liver function: one of ALT, conjugated bilirubin, AST, ALP and total bilirubin > 2 times the upper limit of normal value; Serious renal dysfunction: Cr clearance rate = 180/110 mm Hg (WHO-ISH hypertension guideline grade 3 hypertension); 8) Identify/suspect abuse or long-term use of narcotic sedative-analgesics; 9) Hyperthyroidism; 10) Patients with high intraocular pressure such as glaucoma; 11) Reoperation within 3 months; 12) There are contraindications or allergies to test drugs and other narcotic drugs; 13) patients who plan to enter ICU after operation; 14) Patients who participated in other studies within 30 days. 15) Patients with severe respiratory complications.

Design outcomes

Primary

MeasureTime frame
delirium;

Secondary

MeasureTime frame
come round quality;Incidence of pain;Outcome situation;

Countries

China

Contacts

Public ContactZhang Jia Qiang

Henan Province People's Hospital

hnmzxh@163.com+86 13937121360

Outcome results

None listed

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