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Effect of subanesthetic dose esketamine on sleep in elderly patients after general anesthesia

Effect of subanesthetic dose esketamine on sleep in elderly patients after general anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084862
Enrollment
Unknown
Registered
2024-05-27
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

postoperative sleep disturbance

Interventions

Esketamine Group (K Group):Maintenance period: When the skin was peeled,the administration rate was 0.3mg/kg/h.
Normal saline group (N group):Maintenance period: When the skin was peeled,the administration rate was 0.3mg/kg/h.

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 range 65-80 years old. 2. Patients with the American Society of Anesthesiologists ASA body status classification I through III(where I indicates healthy patients, II indicates patients with mild systemic disease, and III indicates patients with severe systemic disease). 3. Laparoscopic surgery under general anesthesia was limited to laparoscopic cholecystectomy, laparoscopic choledochotomy and drainage, and laparoscopic partial hepatectomy. 4. The guardian of the study object clearly understands and voluntarily participates in the study, and the informed consent is signed by the guardian of the study object.

Exclusion criteria

Exclusion criteria: 1. Patient refused to participate in the study; 2. History of mental illness, such as anxiety, depression, schizophrenia; 3. Recent history of drug abuse; 4. Take any sedative before surgery; 5. The Pittsburgh Sleep Quality index (PSQI) was higher than 7.5 before surgery; 6. Body mass index (calculated as weight in kilograms divided by height in meters squared) greater than 30; Cognitive impairment or inability to communicate (brain injury, stroke, epilepsy, Parkinson's or Alzheimer's disease, etc.); 8. Any other conditions for which esketamine is not appropriate and which the investigator considers inappropriate for participation in the study (emergency surgery: hypovolemia, shock, or coma; Plan to use other anesthesia methods besides general anesthesia; Infectious heart disease; Abnormal clotting function, anemia or thrombocytopenia; Abnormal liver and kidney function; Allergic or contraindicated to benzodiazepines, opioids, propofol, muscle laxatives and their components; People who are judged to have difficulty managing their respiratory tract)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Sleep disorder assessment;Evaluation of post-operative depression;Postoperative pain evaluation;Postoperative consumption of nalbuphine and postoperative complications;Intraoperative indexes were recorded;

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