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Feasibility of esketamine non-opioid anesthesia for gynecological laparoscopic surgery - a randomized controlled trial

Feasibility of esketamine non-opioid anesthesia for gynecological laparoscopic surgery - a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085340
Enrollment
Unknown
Registered
2024-06-05
Start date
2023-03-25
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Gynecological laparoscopic surgery

Interventions

Opioid free group :Opioid free group anesthesia induction: Esketamine 0.5mg/kg, propofol 2.5mg/kg, rocuronium 0.6mg/kg Opioid free group anesthesia maintenance:Esketamine and rocuronium will be pumped
opioid group:opioid group anesthesia induction: Sufentanil 0.3µg/kg, propofol 2.5mg/kg, rocuronium 0.6mg/kg opioid group anesthesia maintenance: Sufentanil and rocuronium will be pumped continuously

Sponsors

Shandong University Qilu Hospital Dezhou Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing laparoscopic surgery due to gynecological benign diseases, such as ovarian cysts, uterine fibroids, endometriosis, etc.; 2) Age: 18~60 years old; 3) ASA ?~? grade; 4) BMI=32kg/m²; 5) It indicates that it can cooperate with the investigation and provide clear evaluation data of postoperative nausea and vomiting, such as incidence and severity.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of substance abuse or opioid dependence; 2) Pregnant or nursing patients; 3) Patients with a history of allergy to esketamine or other related drugs; 4) Intraoperative conversion to laparotomy or operation time > 2h; 5) Patients with serious cardiovascular diseases and hyperthyroidism; 6) Patients at risk for increased cranial or intraocular pressure; 7) Patients with poorly controlled or untreated hypertension (resting arterial pressure >180/100 mmHg); 8) Patients with preoperative consciousness disorder or unable to cooperate with the interviewer due to other reasons

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative nausea and vomiting;

Secondary

MeasureTime frame
The severity of postoperative nausea and vomiting;Hemodynamic index;Pain score;

Countries

China

Contacts

Public ContactXiangshuang Yao

Shandong University Qilu Hospital Dezhou Hospital

437161130@qq.com+86 185 0534 2973

Outcome results

None listed

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