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Effect of a Single Intraoperative Injection of Low-Dose Esketamine on Postoperative Recovery Quality in Ambulatory Laparoscopic Cholecystectomy: A Randomized Controlled Clinical Trial

Effect of a Single Intraoperative Injection of Low-Dose Esketamine on Postoperative Recovery Quality in Ambulatory Laparoscopic Cholecystectomy: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117446
Enrollment
Unknown
Registered
2026-01-23
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Laparoscopic Cholecystectomy

Interventions

Esketamine Group:Intravenous injection of esketamine (0.25 mg/kg) was administered 3 minutes prior to skin incision
Control Group:An equivalent volume of normal saline was intravenously administered 3 minutes prior to skin incision

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old (including the boundary values); 2. Patients scheduled for elective day-case laparoscopic cholecystectomy; 3. American Society of Anesthesiologists (ASA) classification I-II; 4. Able to understand and complete the QoR-15 questionnaire independently; 5. Voluntarily participating in this study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have experienced pain before surgery for any reason and those taking analgesics; 2. Severe cardiovascular or pulmonary diseases (such as decompensated heart failure, severe chronic obstructive pulmonary disease); 3. Allergic to esketamine or related anesthetics; 4. Patients with a high risk of hypertension or increased intracranial pressure; 5. Patients with poorly controlled or untreated hypertension; 6. Patients with untreated or inadequately treated hyperthyroidism; 7. Severe liver, kidney, neurological, or metabolic diseases; 8. History of psychiatric disorders or long-term use of antipsychotic drugs; 9. Vulnerable populations, including individuals with psychiatric disorders, cognitive impairments, critically ill patients, pregnant women, illiterate individuals, etc.; 10. Other conditions that the investigator believes make the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Total QoR-15 Score on the First Postoperative Day;

Secondary

MeasureTime frame
Total preoperative QoR-15 score;Dimension-specific QoR-15 scores on the first postoperative day;Visual Analogue Scale (VAS) pain scores at rest and during movement in the Post-Anesthesia Care Unit (PACU), at 6 hours postoperatively, and at discharge;Blood pressure and heart rate before anesthesia, at 5 minutes after tracheal intubation, at 5 minutes after tracheal extubation, upon discharge from PACU, and at hospital discharge;Post-Anesthesia Recovery (PAR) score in the PACU;PACU length of stay;Time to first postoperative ambulation (h);Adverse events, including nausea, vomiting, shoulder pain, myalgia, and psychiatric symptoms such as dizziness and hallucinations;Day-case clinical pathway completion rate;

Countries

China

Contacts

Public ContactChen Gang

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@zju.edu.cn+86 137 5711 8681

Outcome results

None listed

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