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.
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
• 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
Single group
NOL guided intraoperative analgesia
DeviceThe 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.
Total opioid requirement during surgery and PACU stay
Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)
Reduction in time to extubation
Reduction in time to extubation measured in minutes
Reduction in time to PACU discharge readiness
Reduction in time to PACU discharge readiness measured in minutes
Modified Aldrete Score
Modified Aldrete Score (scale of 0-10)
Reduction in PACU pain intensity rating
Reduction in PACU pain intensity rating (NRS scale of 0-10 )
Ward recovery metrics - patient satisfaction levels
Patient reported satisfaction levels using standard QoR15 questionnaire responses in the NOL arm only
Intraoperative metrics - Hemodynamic instability
Reduction in hemodynamic instability (hypertensive are MAP above 120mmHg, hypotensive events are MAP below 65mmHg)
Intraoperative metrics - vasocative medication requirement
Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) total doses in mgs.
Ward recovery metrics - Pain Intensity
Pain intensity. Time points: NRS pain score on a scale of 0-10 , measurement frequency per hospital standard of care.
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Medasense Biometrics Ltd
Lead sponsor
Thomas Jefferson Health
Collaborator
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