Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy

NCT07187765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2026-01-05

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187765 on ClinicalTrials.gov