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Efficacy and Safety of Different Doses of Oliceridine Fumarate Injection Combined with Propofol for Painless Gastrointestinal Endoscopy:A Randomized Controlled Trial

Efficacy and Safety of Different Doses of Oliceridine Fumarate Injection Combined with Propofol for Painless Gastrointestinal Endoscopy:A Randomized Controlled TrialDose-Response Efficacy and Safety of Oliceridine Fumarate Combined with Propofol for Sedation During Gastrointestinal Endoscopy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100399
Enrollment
Unknown
Registered
2025-04-08
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

painless gastroenteroscopy

Interventions

0.01mg/kg Oliceridine group:Intravenous 0.01mg/kg Oliceridine
0.015mg/kg Oliceridine group:Intravenous 0.015mg/kg Oliceridine
0.02mg/kg Oliceridine group:Intravenous 0.02mg/kg Oliceridine
0.1ug/kg sufentanil group:Intravenous 0.1ug/kg sufentanil

Sponsors

Wenzhou Medical University Lishui Hospital, Lishui People's Hospital, Lishui, Zhejiang 323000, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.patients undergoing elective painless gastroenteroscopy; 2.18 to 65 years old; 3.American Society of Anaesthesiologists (ASA) classification I to II; 4.cardiac function I or II; 5.BMI 18 to 28 kg/m^2.

Exclusion criteria

Exclusion criteria: 1. patients with contraindications to routine endoscopic procedures or who refuse sedation; 2. history of severe neurological and cardiac, pulmonary, cerebral, and renal diseases (e.g., gastroesophageal reflux, uncontrolled hypertension, diabetes mellitus, and heart disease); 3. acute upper gastrointestinal bleeding with shock; 4. severe anaemia; 5. Gastrointestinal obstruction with retention of gastric contents; 6. long-term drug dependence and psychiatric patients; 7. severe liver function abnormalities; 8. subjects judged to have difficulty with respiratory management with a Modified Mars Score of IV; 9. known or suspected hypersensitivity or contraindication to various components of the study drug, opioids, propofol, etc; 10. those who have participated as a subject in any clinical trial within 3 months prior to enrolment; 11. other conditions judged by the investigator to be unsuitable for enrolment.

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure;heart rate;SpO2;Sedation score;

Secondary

MeasureTime frame
Dosage of propofol;Induction time;Gastroenteroscopy time;awakening time;out-of-home time;Intraoperative and postoperative adverse reactions;VAS pain score;satisfaction rating;

Countries

China

Contacts

Public ContactXu Qiaomin

Wenzhou Medical University Lishui Hospital, Lishui People's Hospital, Lishui, Zhejiang 323000, China

xuqiaomin810@163.com+86 189 5709 2672

Outcome results

None listed

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