Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy

NCT ID: NCT07187765

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2025-12-01

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.

Conditions

Hypoxemia During Surgery; Gastrointestinal Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oliceridine Group

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.

Group Type: EXPERIMENTAL

Oliceridine

Intervention Type: DRUG

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.

Sufentanil Group

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.

Group Type: ACTIVE_COMPARATOR

Sufentanil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TRV130; Sufentanil Citrate

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyou Wei

OTHER

Sponsor Role: lead

Responsible Party

Shiyou Wei

Department of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shiyou Wei, PhD

Role: STUDY_CHAIR

上海市肺科医院

Locations

Tianmen First People's Hospital

Tianmen, Hubei, China

Countries

China

Other Identifiers

20250254

Identifier Type: -

Identifier Source: org_study_id