Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy

NCT07187765 | Completed DMC

• 1 other identifier: 20250254
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia During Surgery; Gastrointestinal Endoscopy

Keywords

Hypoxemia; Gastrointestinal Endoscopy; Oliceridine; Sufentanil; Deep Sedation

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy

  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.

  From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)

Secondary Outcomes (1)

• 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)

Other Outcomes (4)

• Number of participants requiring hypoxemia rescue interventions

  From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)

• Total propofol dose administered

  From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes)

• Incidence of opioid-related adverse events within 1 hour post-procedure

  1 hour after endoscopic procedure

Study Arms (2)

Oliceridine Group

EXPERIMENTAL

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.

Drug: Oliceridine

Sufentanil Group

ACTIVE COMPARATOR

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.

Drug: Sufentanil

Interventions

Oliceridine 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.

Also known as: TRV130

Oliceridine Group

Sufentanil 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.

Also known as: Sufentanil Citrate

Sufentanil Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shiyou Wei: lead

Study Sites (1)

Tianmen First People's Hospital

Tianmen, Hubei, 431700, China

Location

MeSH Terms

Conditions

Hypoxia

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shiyou Wei, PhD

  上海市肺科医院

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and investigators will be blinded to group allocation. Study medications (Oliceridine or Sufentanil) will be prepared in identical syringes by a nurse not involved in patient care or outcome assessment, ensuring that neither patients nor clinicians are aware of the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 23, 2025
• Study Start: September 22, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)