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Determination of the ED90 of Oliceridine for Preventing Acute Pain Following Gynecologic Laparoscopic Ovarian Cyst Surgery: A Biased Coin Up-and-Down Sequential Allocation Trial

Determination of the ED90 of Oliceridine for Preventing Acute Pain Following Gynecologic Laparoscopic Ovarian Cyst Surgery: A Biased Coin Up-and-Down Sequential Allocation Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108306
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-09-03
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Gynecologic Laparoscopic Ovarian Cyst Surgery

Interventions

Experimental group:Following specimen resection, the intravenous dose of oliceridine for the first enrolled patient was set at 20 µg·kg?1. Subsequent patients' doses were adjusted based on the precedi
if no pain occurred, the dose had an 89% probability of remaining unchanged and an 11% probability of increasing by 5 µg·kg?1. If moderate-to-severe pain was observed in the 45 µg·kg?1 group or no pai

Sponsors

Anqing Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 65 years; (2) Patients scheduled to undergo elective gynecologic laparoscopic surgery; (3) Body mass index (BMI) between 18 and 32 kg/m²; (4) Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) History of sedative or analgesic abuse; (2) Allergy or intolerance to anesthetic agents; (3) Hearing or speech impairment precluding effective communication; (4) Pre-existing severe cardiac/pulmonary dysfunction, hepatic/renal insufficiency, uncontrolled hypertension/diabetes, or other organ dysfunction with ASA physical status >III; (5) Patient and/or legal guardian refusal to participate.

Design outcomes

Primary

MeasureTime frame
Whether moderate-to-severe acute pain occurred within 1 hour after surgery;

Secondary

MeasureTime frame
NRS scores at 2h, 6h, 12h, and 24h postoperatively;Number of rescue analgesic administrations within 24 hours postoperatively;QoR-15 scale scores at 24 hours postoperatively;Time to first postoperative flatus;Incidence of adverse reactions including postoperative nausea and vomiting (PONV);

Countries

China

Contacts

Public ContactDuan Jinjuan

Anqing Municipal Hospital

djjayd223@163.com+86 189 0966 5698

Outcome results

None listed

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