Intravenous Oliceridine and Opioid-related Complications: VOLITION: A Multicenter Pilot Cohort Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Number of patients who have respiratory compromise.
研究概览
简要总结
The investigator will evaluate the side effects of oliceridine.
详细描述
The investigator will evaluate the side effects of oliceridine. Limited information suggests that oliceridine may cause fewer side effects than the standard opioids given post surgery. Oliceridine is effective for treating acute pain, and is approved by the FDA. Patients will wear a device that continuously monitors breathing. Data from this monitor will be blinded to the clinical staff. Primary Aims include: The investigators will evaluate the proportion of patients having an adjudicated meaningful respiratory compromise with a specified precision of 0.15 using a 95% confidence interval at 24 hours post first study dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •American Society of Anesthesiologists physical status 1-4
- •Scheduled for major noncardiac surgery expected to last at least 2 hours
- •Expected to remain hospitalized at least two postoperative nights
- •Scheduled for general endotracheal, spinal anesthesia, or the combination
- •Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents
- •Expected to have patient-controlled intravenous analgesia.
排除标准
- •Are demented or otherwise cannot provide valid consent
- •Have contraindications to oliceridine
- •Used legal or illegal opioids chronically, defined as >15 mg morphine equivalents for >15 days during the month before consenting by history
- •Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring
- •Have planned epidural anesthesia/analgesia
- •Planned spinal morphine administration
- •Are designated Do Not Resuscitate, hospice, or receiving end of life therapy
- •Are expected to require postoperative mechanical ventilation or ICU admission
- •Are expected to receive intrathecal opioids
- •Are expected to receive gabapentin, pregabalin or other analgesic adjuvants
- •Use oxygen at home
- •Are unwilling or unable to comply fully with study procedures (including not tolerating the capnography cannula)
- •Are known to be pregnant or breastfeeding
- •Use CPAP at home
- •Have previously participated in the trial
研究组 & 干预措施
Oliceridine
Patients receive Oliceridine for pain control.
干预措施: Oliceridine (Drug)
结局指标
主要结局
Number of patients who have respiratory compromise.
时间窗: 24 hours post first study dose.
Respiratory compromise will be defined by a collapsed (one or more) composite of 1) end-tidal carbon dioxide \<15mmHg for ≥3 minutes; 2) respiratory rate ≤5 breaths/minute for ≥3 minutes; 3) SpO2 ≤ 85% for ≥3 minutes; 4) Apnea episode lasting \>30 seconds; 5)any serious respiratory event.
次要结局
- Cumulative duration of oxygen saturation < 90%(48 hours post first study dose.)
- Cumulative duration of respiratory rate < 8 breaths/ minute(48 hours post first study dose.)