Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Medasense Biometrics Ltd
Study ID
NCT07608276
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Anesthesia , Analgesia
  • Pain After Surgery
  • Spine Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Retrospective cohort
    A retrospective arm will be case matched from the hospital's EMR system.

Primary Outcome Measure

Total opioid requirement during surgery and PACU stay [ Time Frame: One day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Jaime Baratta, MD
[email protected]
215-955-6161

Find similar trials in Philadelphia, PA

By research site
Thomas Jefferson University Hospital· Philadelphia, PA

Related Studies