Postoperative Benefits of Intraoperative NOL Titration - Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- PACU pain score
研究概览
简要总结
Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Anesthesia clinicians cannot be blinded since they will need to titrate opioid administration to NOL. However, all postoperative care and evaluations will be fully blinded to randomization, thus preventing measurement bias
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults having major non-cardiac surgery expected to last ≥2 hours;
- •American Society of Anesthesiologists physical status 1-3;
- •Age 21-85 years old;
- •Planned endotracheal intubation
排除标准
- •Planned neuraxial or regional block;
- •Local anesthetic infiltration at surgical field;
- •Clinician preference for an opioid other than, or in addition to, fentanyl;
- •Non-sinus heart rhythm;
- •Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
- •Lack of English language fluency;
- •Routine user of psychoactive drugs other than opioids;
- •Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
- •Intracranial surgery
结局指标
主要结局
PACU pain score
时间窗: 60 minutes during recovery
Average pain scores (0-10 verbal response scale) at 10-minute intervals during the initial 60 minutes of recovery are more often between 1 and 3 or significantly lower with NOL-guided fentanyl than with routine care
次要结局
未报告次要终点