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NCT Number: NCT07187765

Respiratory Safety of Oliceridine During Sedated Gastrointestinal Endoscopy

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.

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Key information

Conditions

Hypoxemia During Surgery Gastrointestinal Endoscopy Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianmen First People's Hospital

Tianmen, Hubei, 431700, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: TRV130

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.

Other names: Sufentanil Citrate

Primary outcomes

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

    Time frame: 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 outcomes

  1. Incidence of secondary hypoxemic events during sedation for gastrointestinal endoscopy

    Time frame: 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 :

    • Severe hypoxemia, defined as lowest SpO₂ ≤ 85%
    • A drop in SpO₂ of > 5% relative to the participant's highest measured value during the sedation period

Other outcomes

  1. Number of participants requiring hypoxemia rescue interventions

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

    Number of participants who, during sedation, required one or more of the following airway/ventilatory rescue measures to treat hypoxemia: none, mask ventilation, jaw-thrust maneuver, tracheal intubation, or other.

  2. Total propofol dose administered

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

    Cumulative amount of propofol (in mg) administered intravenously to each participant for sedation during the endoscopic procedure.

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

    Time frame: 1 hour after endoscopic procedure

    Proportion of participants experiencing any of the following within the first hour after procedure completion: nausea, vomiting, hypoxemia, pruritus, or dizziness.

  4. Incidence of intra-procedural anesthesia-related adverse events

    Time frame: From initiation of sedation to completion of endoscopic procedure

    Proportion of participants who, during sedation, experienced any of: procedure interruption due to anesthesia (e.g. patient movement, hypoxemia), bradycardia, tachycardia, hypotension, hypertension, or required administration of vasoactive medications (vasopressors or chronotropes).

Sponsors and collaborators

Lead sponsor

Shiyou Wei

Other

Registry information

Official study title

Respiratory Safety of Oliceridine in Propofol-Sedated Gastrointestinal Endoscopy: A Double-Blind, Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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