Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The objective of this study is to evaluate the clinical impact of the NOL nociception level index monitoring on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort.
详细描述
The study will assess the impact of intraoperative use of NOL nociception monitoring in in-hospital spine surgery procedures performed under general anesthesia on post operative patient outcomes. The study is designed as a quality improvement project with the prospective outcomes to be compared to a retrospective matched cohort. The objective of this study is to evaluate the clinical impact of the device on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort. The clinical impact will also be translated into economic metrics.
Secondary endpoints
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Reduction in time to extubation
-
Reduction in time to PACU discharge readiness
-
Reduction in anesthesia related adverse events:
-
PONV
-
Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring
-
Somnolence
-
Sedation (Pasero score)
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Discharge readiness (modified Aldrete score)
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PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints
INTRAOPERATIVE
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age > 18 years old.
- •ASA I-III
- •Elective spine surgery (laminectomy, spinal fusion, and disc replacement) under general anesthesia.
- •Opioid tolerant and patients with documented chronic pain may be included
- •Patient able to provide informed consent
排除标准
- •• Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia)
- •Use of intraoperative methadone
- •Non-sinus heart rate
- •Pregnancy/lactation
- •Chronic use of psychoactive drugs within 90 days prior to surgery
- •Patients currently using IV opioids (IV drug abuse)
- •Allergy or intolerance to any of the study anesthesia related drugs
- •History of severe cardiac arrhythmias within the last 12 months
- •Surgeries less than 1.5 hours (from incision to extubation)