Respiratory Safety of Oliceridine in Propofol-Sedated Gastrointestinal Endoscopy: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Oliceridine (Drug)
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.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Incidence of Hypoxemia (SpO₂ ≤92%) During Sedation for Gastrointestinal Endoscopy
时间窗: 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.
次要结局
- 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))
研究者
Shiyou Wei
Department of Anesthesiology
Shanghai Pulmonary Hospital, Shanghai, China