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The therapeutic effect of esketamine on postoperative analgesia in gynecological laparoscopic surgery: A single-center, prospective, randomized controlled trial

The therapeutic effect of esketamine on postoperative analgesia in gynecological laparoscopic surgery: A single-center, prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075533
Enrollment
Unknown
Registered
2023-09-07
Start date
2023-09-11
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Postoperative pain, nausea and vomiting

Interventions

Esketamine Group(E Group):A single dose of esketamine 0.25 mg /kg is to inject intravenously as laparoscopic withdrawal. After extubation, a single dose of esmketamine 0.1mg/kg is to inject intraveno
Sufentanil Group(S Group):A single dose of sufentanil 0.1µg/kg is to inject intravenously as laparoscopic withdrawal. After extubation, a single dose of sufentanil 0.04µg/kg is to inject intravenously

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Patients and their legal representatives voluntarily participated in the study and signed informed consent. (2) Patients undergoing elective surgery in the Department of gynecology of our hospital, who planned to undergo laparoscopic surgery with endotracheal intubation under general anesthesia, and estimated operation time under 2 hours; (3) Age of 18-60 years old; (4) Preoperative Mallampati grade I-II.

Exclusion criteria

Exclusion criteria: (1) History of taking psychotropic drugs within 3 days before surgery; (2) Unable to complete visual analogue scale (VAS) test or psychological assessment independently; (3) History of severe neuropathic pain such as migraine, diabetic peripheral neuropathy, postherpetic neuralgia, trigeminal neuralgia, post-traumatic neuralgia, phantom limb pain; (4) History of severe craniocerebral trauma or hemorrhage or cerebral infarction; (5) patients with contraindications to ketamine and esketamine; (6) complicated with severe mental illness; (7) abdominal lymph node dissection is required; (8) patients deemed by other investigators to be ineligible for enrollment.

Design outcomes

Primary

MeasureTime frame
VAS grade of Postoperative nausea and vomiting(PONV);

Secondary

MeasureTime frame
VAS grade of wound pain;Dosage and effect of analgesic drugs;The time of first exsufflation;

Countries

China

Contacts

Public ContactLi Xiang

The Third Affiliated Hospital of Sun Yat-sen University

lixiang27@mail.sysu.edu.cn+86 156 0239 1780

Outcome results

None listed

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