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Efficacy and safety of oliceridine in peri-operative analgesia for patients with urethral stricture: A single-center, randomized, double-blind, positive drug standard-controlled clinical trial (The OliUS Trial)

Feasibility, efficacy, and safety of Oliceridine in perioperative analgesia for patients with urethral stricture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109984
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Urethral stricture

Interventions

Oliceridine group:During anesthesia induction, oliceridine 3 mg (3 mL) was administered intravenously, followed by another 3 mg (3 mL) during skin closure. Intraoperative supplemental doses of oliceri
Sufentanil group:During anesthesia induction, sufentanil 15 µg (3 mL) was administered intravenously, followed by another 15 µg (3 mL) during skin closure. Intraoperative supplemental doses of sufenta

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male patients scheduled for urethral repair and reconstruction surgery under general anesthesia; 2. Aged between 18 and 65 years; 3. American Society of Anaesthesiologists (ASA) physical status classification of I~III; 4. Body Mass Index (BMI) ranging from 18 to 30 kg/m^2; 5. Patients or their authorized family members have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There are contraindications for the use of oliceridine (such as severe respiratory depression, paralytic ileus, or allergy to oliceridine); 2. Long-term use of opioids or tolerance to opioids; 3. Severe impairment of heart, lung, liver or kidney function; 4. Allergy to other drugs involved in this study; 5. Illiteracy or communication difficulties; 6. Participation in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Post-operative 6-hour NRS scale pain score;

Secondary

MeasureTime frame
Post-operative static and dynamic pain scores and the incidence of moderate to severe static pain within 24 hours after surgery;The time of the first rescue analgesia after surgery and the number of rescue analgesia administration;Patient satisfaction scores for post-operative analgesia;Post-operative nausea and vomiting (PONV) grading;Post-operative respiratory depression and subclinical respiratory depression;Ramsay sedation score;Post-operative Athens Insomnia Scale (AIS) score;Intra-operative QTc interval;The score of the Europe Health-Related Quality of Life Questionnaire 5 Dimensions (EQ-5D);Time to first ambulation post-operatively;Inflammatory factor;Other adverse events;

Countries

China

Contacts

Public ContactDong Yushan

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

practitioner_dys@foxmail.com+86 139 5630 9323

Outcome results

None listed

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