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

Medasense

Status: Not yet enrolling

Conditions: Spine Surgery; Anesthesia , Analgesia; Pain After Surgery

Treatments: Device: NOL guided intraoperative analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07608276

NOL Monitoring Spine Surgery

Details and patient eligibility

About

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.

Full 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 when compared to a case controlled retrospective cohort. The clinical impact will also be translated into economic metrics.

Secondary endpoints

1. Reduction in time to extubation

2. Reduction in time to PACU discharge readiness

3. Reduction in anesthesia related adverse events:

   1. PONV
   2. 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
   3. Somnolence
   4. Sedation (Pasero score)
   5. Discharge readiness (modified Aldrete score)
   6. PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints

INTRAOPERATIVE

1. Reduction in hemodynamic instability (hypertension, hypotensive events)
2. Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine)
3. Association between time spent with NOL values above 25 and PACU pain intensity ratings

WARD - up to 48 hours post surgery

1. Patient reported satisfaction levels using questionnaire QR15
2. Pain intensity (Time points: NRS according to the SOC))
3. 48 hours post-operative opioid consumption
4. Requirement for Acute Pain Service consultation
5. Reduction in rescue opioid requirements
6. Ketamine prescription on the ward
7. Opioid prescription on the ward
8. PONV medication consumption
9. Clinician survey on the device

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Retrospective cohort

Other group

Description:

A retrospective arm will be case matched from the hospital's EMR system.

Treatment:

Device: NOL guided intraoperative analgesia