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| Name | Class |
|---|---|
| Thomas Jefferson Health | UNKNOWN |
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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.
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
Reduction in time to extubation
Reduction in time to PACU discharge readiness
Reduction in anesthesia related adverse events:
INTRAOPERATIVE
WARD - up to 48 hours post surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | Other | A retrospective arm will be case matched from the hospital's EMR system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOL guided intraoperative analgesia | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid requirement during surgery and PACU stay | Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs) | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in time to extubation | Reduction in time to extubation measured in minutes | one day |
| Reduction in time to PACU discharge readiness | Reduction in time to PACU discharge readiness measured in minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Ward recovery metrics - patient satisfaction levels | Patient reported satisfaction levels using standard QoR15 questionnaire responses in the NOL arm only | three days |
| Intraoperative metrics - Hemodynamic instability |
Inclusion Criteria:
Exclusion Criteria:
• Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Baratta, MD | Contact | 215-955-6161 | Jaime.Baratta@jefferson.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30829658 | Background | Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634. | |
| 41464862 | Background | Khalaila A, Hasan M, Berkovich Y, Sleiman A, Mangoubi E, Grach M, Ibrahim U, Gutman Tirosh A, Shpigelman D, Shpigelman A. Intraoperative Nociception Monitoring Using the NoL Index: Phase-Specific Assessment of Nociceptive Responses During Spinal Surgery. J Clin Med. 2025 Dec 18;14(24):8960. doi: 10.3390/jcm14248960. |
| Label | URL |
|---|---|
| Related Info | View source |
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This is a pilot project and we have not envisioned working wth other centers on this project.
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|
| one day |
| Modified Aldrete Score | Modified Aldrete Score (scale of 0-10) | one day |
| Reduction in PACU pain intensity rating | Reduction in PACU pain intensity rating (NRS scale of 0-10 ) | one day |
| Anesthesia Related Adverse Events - PONV | PONV in PACU assessed used accepted PONV symptom scale (0-4) | 1 day |
| Anesthesia Related Adverse Events in PACU - Respiratory Depression | 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 | one day |
| Anesthesia Related Adverse Events in PACU - Sedation & Somnolence | Sedation & Somnolence using Pasero Scale (S 1-4) | one day |
Reduction in hemodynamic instability (hypertensive are MAP above 120mmHg, hypotensive events are MAP below 65mmHg)
| One day |
| Intraoperative metrics - vasocative medication requirement | Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) total doses in mgs. | One day |
| 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. | three days |
| Intraoperative metrics - nociception levels during surgery | Correlation between time spent with NOL values above 25 (range 0-100 no unit of measurement) and PACU pain intensity ratings measured using the NRS scale (0-10) - to be assessed in the NOL arm only | One day |
| Ward recovery metrics - post operative opioid consumption | 48 hours post-operative opioid consumption measured in morphine equivalents in mgs. | three days |
| Ward recovery metrics - Requirement for Acute Pain Service consultation | Requirement for Acute Pain Service consultation (Y/N) | three days |
| Ward recovery metrics - reduction in rescue opioid requirements | Reduction in rescue opioid requirements - morphine equivalents in mgs | three days |
| Ward recovery metrics - Ketamine requirement | Ketamine prescription on the ward (mgs) | three days |
| Ward recovery metrics - Opioid requirement on the ward | number of opioid prescriptions and total amount in morphine equivalents (mgs) | three days |
| Ward recovery metrics - PONV | PONV medication consumption in mgs | three days |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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