Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot
Medasense Biometrics Ltd
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * • 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 current…
Interventions
- DeviceNOL guided intraoperative analgesia
The PMD-200 monitor with the NOL index will be used to guide analgesia dosing during anesthesia maintenance as an adjunct monitor used alongside other anesthesia monitors. If the NOL value is above 25 for sixty seconds or more, clinicians will evaluate whether more analgesia is needed. If the NOL value is below 25 the patient is considered to have adequately managed nociception.
Location
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania