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Effects of Intraoperative Subanesthetic Dose Esketamine Infusion on Postoperative Sleep Disorders in Elderly Patients Following Laparoscopic Gastrointestinal Tumor Resection Surgery: A Randomized Controlled Study

Effects of Intraoperative Subanesthetic Dose Esketamine Infusion on Postoperative Sleep Disorders in Elderly Patients Following Laparoscopic Gastrointestinal Tumor Resection Surgery: A Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087222
Enrollment
Unknown
Registered
2024-07-23
Start date
2024-08-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Gastrointestinal tumors

Interventions

the group of esketamine:From skin incision to abdominal closure, esketamine was continuously infused at a rate of 0.1 mg·kg?1·h?1, with the remainder of general anesthesia maintained according to rou
The normal saline group.:From skin incision to abdominal closure, an equal volume of normal saline was administered, with the remainder of general anesthesia maintained according to routine protocols.

Sponsors

The Second Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 65 and 80 years old, gender not limited. 2. American Society of Anesthesiologists (ASA) physical status classification I to III. 3. Body Mass Index (BMI) between 18 to 30 kg/m^2. 4. Scheduled to undergo elective laparoscopic gastrointestinal surgery under general anesthesia.

Exclusion criteria

Exclusion criteria: 1.Patients who refuse to participate in the study. 2.Long-term use of analgesic drugs or psychotropic medications, with contraindications to or addiction to opioids and esketamine. 3.History of severe renal or hepatic dysfunction, or delayed recovery from general anesthesia. 4.Preoperative Pittsburgh Sleep Quality Index (PSQI) score higher than 7. 5.History of schizophrenia, epilepsy, or neurodegenerative diseases (Alzheimer's disease and Parkinson's disease). 6.Preoperative delirium or communication disorders.

Design outcomes

Primary

MeasureTime frame
The incidence of sleep disturbance on postoperative day 1 (POD 1). Subgroup analysis was performed according to patient age (65–70 years, 71–75 years, and 76–80 years) to explore the differential effects of the intervention on the incidence of sleep disturbance on POD 1 across the three age groups.;

Secondary

MeasureTime frame
The incidence of sleep disturbance on postoperative days 2–3 (POD 2–3).;postoperative sleep quality;postoperative anxiety and depression;intraoperative opioid consumption (sufentanil and remifentanil);postoperative pain score;the number of effective bolus demands via postoperative patient-controlled intravenous analgesia (PCIA);the incidence of postoperative adverse reactions (nausea and vomiting, dizziness, hallucination, and respiratory depression);plasma biomarkers;

Countries

China

Contacts

Public ContactHe Xingying

The Second Affiliated Hospital of Naval Medical University

beforesunrisel@163.com+86 183 2628 6642

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 9, 2026