Hypoxemia During Surgery, Gastrointestinal Endoscopy
Conditions
Keywords
Hypoxemia, Gastrointestinal Endoscopy, Oliceridine, Sufentanil, Deep Sedation
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.
Interventions
DRUGOliceridine
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.
DRUGSufentanil
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
Shiyou Wei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of opioid-related adverse events within 1 hour post-procedure | 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. |
| Number of participants requiring hypoxemia rescue interventions | 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. |
| Total propofol dose administered | 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. |
| Incidence of intra-procedural anesthesia-related adverse events | 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). |
Countries
China
Outcome results
None listed