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Evaluation of the Analgesic Efficacy of Stepwise Pulse Administration of Oliceridine, a Novel Biased µ-Opioid Receptor Agonist, for Postoperative Patient-Controlled Analgesia

Evaluation of the Analgesic Efficacy of Stepwise Pulse Administration of Oliceridine, a Novel Biased µ-Opioid Receptor Agonist, for Postoperative Patient-Controlled Analgesia - ESP-Oli PCA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124098
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-05-07
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

postoperative pain

Interventions

Oliceridine group:30 mg of oliceridine fumarate is diluted with 0.9% normal saline to a total volume of 150 mL. An initial loading dose of 7.5 mL is administered. When the patient presses the administ
Modified Oliceridine group:For the optimized patient controlled intravenous analgesia (PCIA) regimen using a biased µ?opioid receptor agonist, a stepwise pulse administration mode combined with on dem
Sufentanil group:For the PCIA regimen using sufentanil, the postoperative continuous analgesia concentration is 0.02 µg/(kg·ml) of sufentanil, with an infusion rate of 2 ml/h, a bolus dose of 0.5 ml,

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. ASA physical status I–II 2. BMI 18–24 kg/m² 3. Age 18–50 years 4. Patients scheduled to undergo laparoscopic surgery with an estimated operative time of 2–3 hours

Exclusion criteria

Exclusion criteria: 1. Participation in another clinical trial within 4 weeks prior to the start of this study. 2. Suspected gastrointestinal obstruction, including paralytic ileus. 3. Emergency patients who cannot undergo adequate preoperative preparation. 4. Acute or severe bronchial asthma in an unmonitored setting or without resuscitation equipment. 5. Patients with pre-existing organic heart disease (e.g., sick sinus syndrome, atrioventricular block, etc.). 6. Patients with severe dehydration, electrolyte disturbances, and shock. 7. Female patients who are pregnant, planning pregnancy, or lactating. 8. Patients with pre-existing severe respiratory dysfunction. 9. Patients with a history of neurological or psychiatric disorders, severe alcoholism, or long-term high-dose sedative use.

Design outcomes

Primary

MeasureTime frame
Total analgesic consumption within 48 hours postoperatively;

Secondary

MeasureTime frame
Visual Analogue Scale pain score;The number of PCIA demands and the total analgesic dose administered;The incidence and severity of adverse reactions within 24 hours postoperatively and during the 24–48 hour interval;

Countries

China

Contacts

Public ContactMao Xu

Peking University Third Hospital

anae@163.com+86 10 8226 5176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026