Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy
NCT07187765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 508
Last updated 2026-01-05
Summary
This study is a prospective, single-center, double-blind, randomized controlled trial designed to evaluate the effect of oliceridine versus sufentanil on the incidence of hypoxemia in adult patients undergoing gastrointestinal endoscopy under deep sedation. The trial will compare the rates of hypoxemia (defined as SpO₂ ≤92%) between the two analgesic regimens when combined with propofol. The primary aim is to determine whether oliceridine can reduce the incidence of hypoxemia compared to sufentanil during endoscopic procedures.
Conditions
- Hypoxemia During Surgery
- Gastrointestinal Endoscopy
Interventions
- DRUG
-
Oliceridine
Oliceridine will be administered intravenously at a dose of 1 mg for gastroscopy or 1.5 mg for colonoscopy, in combination with propofol (1-2 mg/kg), to provide sedation and analgesia during gastrointestinal endoscopy.
- DRUG
-
Sufentanil
Sufentanil will be administered intravenously at a dose of 5 μg for gastroscopy or 7.5 μg for colonoscopy, in combination with propofol (1-2 mg/kg), to provide sedation and analgesia during gastrointestinal endoscopy.
Sponsors & Collaborators
-
Shiyou Wei
lead OTHER
Principal Investigators
-
Shiyou Wei, PhD · 上海市肺科医院
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-22
- Primary Completion
- 2025-11-30
- Completion
- 2025-12-01
Countries
- China
Study Locations
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