A Prospective, Randomized, PACU Blinded Study to Compare ANI-guided Analgesic Administration Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The Incidence of Severe Postoperative Pain
研究概览
简要总结
This study aims to be a randomized, controlled study of ANI-guided opioid administration versus standard clinical practice in surgical patients undergoing general anesthesia with balanced sevoflurane-fentanyl. Patients will be randomly assigned to 2 groups- ANI vs. standard care. The intraoperative and postoperative management of all patients will be standardized by protocol. The PACU nurses and postop assessor will be blinded as to which group the patient is in.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years old
- •BMI 19-35 kg/m2
- •Patients undergoing surgery with general anesthesia with sevoflurane- fentanyl
- •Planned abdominal or spinal surgery lasting 1-3 hours
- •Willing and able to consent in English or Spanish
- •No current history of advanced pulmonary or cardiovascular disease
排除标准
- •Age less than 18 or older than 75
- •Patient does not speak English or Spanish
- •Patient refusal
- •Monitored anesthesia care (MAC) or regional anesthesia planned
- •Pregnant or nursing women
- •"Stat" (emergent) cases
- •ECG rhythm other than regular sinus rhythm
- •Implanted pacemakers
- •On antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers
- •Presence of pacemaker
- •Autonomic nervous system disorder
- •Use of chronic opioids
研究组 & 干预措施
Standard opioid administration
Intraoperative opioid will be administered by guiding standard practice
干预措施: Standard opioid administration (Other)
ANI-guided opioid administration
Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)
干预措施: ANI-guided opioid administration (Device)
结局指标
主要结局
The Incidence of Severe Postoperative Pain
时间窗: postoperative recovery period, an average of 1 hour
The primary outcome will be the NRS pain scores reported during recovery
次要结局
- The Incidence of Pain Medication Use(Perioperative and postoperative recovery period)
- The Incidence of Postoperative Nausea/Vomiting in Post-anesthesia Care Unit (PACU)(Postoperative recovery period)
- The Incidence of Minimal Pain(Postoperative recovery period)
研究者
Tiffany B Moon
Associate Professor
University of Texas Southwestern Medical Center