Oliceridine Versus Sufentanil on Hypoxemia Incidence During Sedated Gastrointestinal Endoscopy

Not Applicable

Not yet recruiting

• Conditions: Hypoxemia During Surgery; Gastrointestinal Endoscopy
• Interventions: Drug: Oliceridine; Drug: Sufentanil

• Registration Number: NCT07187765
• Lead Sponsor: Shiyou Wei

Brief 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.

Detailed Description

Gastrointestinal endoscopy is frequently performed under deep sedation to minimize patient discomfort caused by mechanical stimulation. Currently, the combination of propofol and short-acting opioids, such as sufentanil, is widely used for its reliable sedation and analgesia. However, opioid-induced respiratory depression (OIRD) remains a notable concern. Unlike traditional opioids, oliceridine is a synthetic μ-opioid receptor agonist that preferentially activates G protein pathways while substantially reducing β-arrestin pathway activation, which may lower the risk of opioid-related adverse events, including respiratory depression.

Previous studies suggest that oliceridine is as effective as morphine for pain control and may be associated with a lower incidence of adverse effects, particularly in elderly or obese surgical patients. Clinical data also suggest a lower risk of respiratory depression with oliceridine compared to traditional opioids, but the incidence of hypoxemia with oliceridine during real-world deep sedation remains unclear.

This study aims to enroll adult patients (aged ≥18 years, ASA I-III) scheduled for elective gastrointestinal endoscopy. Participants will be randomly assigned (1:1) to receive either oliceridine (1 mg for gastroscopy or 1.5 mg for colonoscopy) or sufentanil (5 μg for gastroscopy or 7.5 μg for colonoscopy), both in combination with propofol (1-2 mg/kg). The primary outcome is the incidence of SpO₂ ≤92% from the start of sedation to the end of the procedure.

Study Timeline

• Study First Submitted: 2025-08-06
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-01
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

• Male or female patients aged ≥ 18 years.
• Scheduled to undergo elective gastrointestinal endoscopy (gastroscopy or colonoscopy).
• American Society of Anesthesiologists (ASA) physical status I-III.
• No history of severe cardiopulmonary dysfunction or other major systemic disease.

Exclusion Criteria

• Dementia or any cognitive impairment precluding provision of informed consent.
• Known contraindication to oliceridine.
• Chronic (long-term) opioid use.
• Any other medical or logistic condition that, in the investigator's judgment, makes the participant unsuitable for the study (specify reason).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oliceridine Group	Oliceridine	Patients in this group will receive intravenous oliceridine (1 mg for gastroscopy or 1.5 mg for colonoscopy) combined with propofol (1-2 mg/kg) for sedation during gastrointestinal endoscopy.
Sufentanil Group	Sufentanil	Patients in this group will receive intravenous sufentanil (5 μg for gastroscopy or 7.5 μg for colonoscopy) combined with propofol (1-2 mg/kg) for sedation during gastrointestinal endoscopy.

Primary Outcome Measures

Name	Time	Method
Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy	From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)	The proportion of participants who experience hypoxemia, defined as a peripheral oxygen saturation (SpO₂) ≤92%, at any time from the start of sedation until the end of the endoscopic procedure.

Secondary Outcome Measures

Name	Time	Method
Incidence of secondary hypoxemic events during sedation for gastrointestinal endoscopy	From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)	The proportion of participants who experience any of the following between the start of sedation and the end of the endoscopic procedure : 1. Severe hypoxemia, defined as lowest SpO₂ ≤ 85%; 2. A drop in SpO₂ of \> 5% relative to the participant's highest measured value during the sedation period

Trial Locations

Locations (1)

Tianmen First People's Hospital; 🇨🇳 Tianmen, Hubei, China