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Effect of intraoperative subanesthetic dose of esketamine on postoperative sleep in elderly patients with preoperative sleep disorders

Effect of intraoperative subanesthetic dose of esketamine on postoperative sleep in elderly patients with preoperative sleep disorders

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095523
Enrollment
Unknown
Registered
2025-01-08
Start date
2025-02-03
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Sleep disorder

Interventions

Experimental group:Start at the time of incision, intraoperative infusion of Esketamine 0.3mg/(kg.h)
Control group:The same amount of normal saline was injected during the operation

Sponsors

Longchang People's Hospital of Sichuan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 65-80 years old; 2 Patients with the American Society of Anesthesiologists ASA physical status classification of I to III (where I indicates healthy patients, II indicates patients with mild systemic disease, and III indicates patients with severe systemic disease); 3. The guardian of the research subject clearly understands and voluntarily participates in the study, and the guardian of the research subject signs the informed consent form; 4. Laparoscopic surgery under general anesthesia, and the type of surgery is limited to laparoscopic cholecystectomy and laparoscopic cholecystectomy.

Exclusion criteria

Exclusion criteria: 1. Patient refuses to participate in the study; 2. Patients with mental illness, such as anxiety, depression, and schizophrenia; 3. History of recent drug abuse; 4. Take any sedative medication before surgery; 5. Preoperative Pittsburgh Sleep Quality Index (PSQI) <=5; 6. Body mass index (calculated in kilograms of weight divided by the square of height meters) above 30; 7. Cognitive dysfunction or inability to communicate (traumatic brain injury, stroke, epilepsy, Parkinson's or Alzheimer's disease, etc.); 8. Any other conditions that do not apply esketamine and are considered inappropriate by the investigator to participate in this study (emergency surgery: hypovolemia, shock, or coma; Combined anesthesia in addition to general anaesthesia is planned; infectious heart disease; coagulation abnormalities, anemia or thrombocytopenia; abnormal liver and kidney function; Those who are allergic or contraindicated to benzodiazepines, opioids, propofol, muscle relaxants and their components; Those who are judged to have difficulties in respiratory management).

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative sleep disorders on the first and third day after surgery;

Secondary

MeasureTime frame
Sleep quality was assessed using the Mi Band kinetograph on the 1st and 3rd day after surgery;Evaluation of postoperative VAS pain at rest and during exercise;Evaluation of anxiety and depression after surgery;Postoperative analgesic drug consumption;Postoperative complication;

Countries

China

Contacts

Public ContactHang Li

Longchang People's Hospital of Sichuan Province

lh0804lucky@163.com+86 832 395 5380

Outcome results

None listed

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