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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of secondary hypoxemic events during sedation for gastrointestinal endoscopy | The proportion of participants who experience any of the following between the start of sedation and the end of the endoscopic procedure :
| From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants requiring hypoxemia rescue interventions | 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. | From the start of sedation to the end of the gastrointestinal endoscopic procedure (approximately 1-60 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyou Wei, PhD | 上海市肺科医院 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianmen First People's Hospital | Tianmen | Hubei | 431700 | China |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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| 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. |
|
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| Total propofol dose administered | Cumulative amount of propofol (in mg) administered intravenously to each participant for sedation during the endoscopic procedure. | 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 | Proportion of participants experiencing any of the following within the first hour after procedure completion: nausea, vomiting, hypoxemia, pruritus, or dizziness. | 1 hour after endoscopic procedure |
| Incidence of intra-procedural anesthesia-related adverse events | 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). | From initiation of sedation to completion of endoscopic procedure |