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Comparison of Oliceridine and Sufentanil in Postoperative Analgesia in Laparoscopic Cholecystectomy:a Randomized Double-Blind Controlled Trial

Comparison of Oliceridine and Sufentanil in Postoperative Analgesia in Laparoscopic Cholecystectomy:a Randomized Double-Blind Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114731
Enrollment
Unknown
Registered
2025-12-17
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

Postoperative pain

Interventions

Group O:Oxycodone 20mg + Azasetron 10mg, diluted to 100ml with 0.9% normal saline. PCIA settings: Loading dose: 2ml, background infusion 0ml/h, bolus dose 2ml, lockout interval 15min, maximum dose 10m
Group S:Control group: Sufentanil 100ug + Azasetron 10mg, diluted to 100ml with 0.9% normal saline
PCIA settings: Initial dose: 2ml, background infusion 0ml/h, single press dose 2ml, lockout time 15min, maximum dose 10ml/h, continuous use for 48 hours.

Sponsors

Tongling People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) ASA grade I–III; (2) Aged 18–75 years, regardless of gender; (3) Scheduled for elective laparoscopic cholecystectomy under general anesthesia; (4) Preoperative resting pain score (NRS) <3; (5) Able to comprehend the study content and cooperate in using pain assessment tools (e.g., NRS score); (6) Intended to receive postoperative intravenous patient-controlled analgesia (PCIA); (7) Voluntarily participated in this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Emergency surgery patients; (2) BMI >=35 kg/m²; (3) History of allergy or contraindication to study drugs (including oliceridine or local anesthetics such as ropivacaine); (4) Severe cardiac, pulmonary, cerebral diseases and/or abnormal liver or kidney function; (5) Cognitive impairment, mental illness, or current use of antipsychotic drugs; (6) History of alcohol or drug abuse, or long-term preoperative use of opioids or other analgesics; (7) Intraoperative conversion to laparotomy, occurrence of severe intraoperative complications, or surgical duration exceeding 90 minutes; (8) Inability to cooperate with postoperative follow-up and related assessments; (9) Refusal by family members or guardians to participate.

Design outcomes

Primary

MeasureTime frame
Area under the curve (AUC) of time-weighted pain scores (NRS, 0–10) during patient movement and rest within 0–48 hours postoperatively;

Secondary

MeasureTime frame
Total postoperative opioid consumption (expressed in morphine equivalents) in the two groups, covering 0–24 h, 24–48 h, and 0–48 h;Number of postoperative analgesic pump presses;Time of first postoperative rescue analgesia, type of drug, and dosage;The occurrence of postoperative opioid-related adverse reactions, including PONV, sedation, pruritus, dizziness, and respiratory depression, etc.;

Countries

China

Contacts

Public ContactGao Zongbin

Tongling People's Hospital

gaozongbin1989@126.com+86 189 5625 0620

Outcome results

None listed

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