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Evaluation of the Safety and Efficacy of Oliceridine for Postoperative Analgesia in Gynecological Laparoscopic Surgery: A Randomized Controlled Trial

Evaluation of the Safety and Efficacy of Oliceridine for Postoperative Analgesia in Gynecological Laparoscopic Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115405
Enrollment
Unknown
Registered
2025-12-25
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

None listed

Interventions

Intervention group:Oliceridine 0.2 mg/kg + flurbiprofen axetil 200 mg + tropisetron 10 mg, diluted to 100 mL with 0.9% sodium chloride injection.
Control group:Sufentanil 2 µg/kg + flurbiprofen axetil 200 mg + tropisetron 10 mg, diluted to 100 mL with 0.9% sodium chloride injection.

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years. 2. Scheduled for elective gynecological laparoscopic surgery, with an anticipated operative duration of less than 3 hours. 3. American Society of Anesthesiologists physical status classification of I to III. 4. Body mass index ranging from 18 kg/m^2 to 26 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic pain requiring long-term use of analgesics or psychotropic drugs, or with alcohol abuse; 2.Known allergy or contraindications to any of the study drugs; 3. Patients with shock, psychiatric disorders, or cognitive dysfunction that would impair cooperation; 4. Acute or chronic bronchial asthma; sleep apnea syndrome; 5. Prolongation of the corrected QT (QTc) interval on electrocardiogram.

Design outcomes

Primary

MeasureTime frame
The total incidence of PONV;

Secondary

MeasureTime frame
Resting and dynamic NRS pain scores at 48 hours postoperatively;Time to first PCA demand;Ramsay Sedation Scale (RSS) Score;QoR-15 Score;Time to first defecation/flatus;

Countries

China

Contacts

Public ContactChen Zhenyi

The First Affiliated Hospital of Xiamen University

cxiaoqin1214@163.com+86 180 6058 5562

Outcome results

None listed

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