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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство NOL 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.

Первичные конечные точки

• Total opioid requirement during surgery and PACU stay [Срок оценки: One day]

Вторичные конечные точки (7)

• Reduction in time to extubation [Срок оценки: one day]
• Reduction in time to PACU discharge readiness [Срок оценки: one day]
• Modified Aldrete Score [Срок оценки: one day]
• Reduction in PACU pain intensity rating [Срок оценки: one day]
• Anesthesia Related Adverse Events - PONV [Срок оценки: 1 day]
• Anesthesia Related Adverse Events in PACU - Respiratory Depression [Срок оценки: one day]
• Anesthesia Related Adverse Events in PACU - Sedation & Somnolence [Срок оценки: one day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Thomas Jefferson University Hospital — Philadelphia

Публикации

• 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. PMID 30829658
• 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. PMID 41464862

Идентификаторы

NCT: NCT07608276 · NOL Monitoring Spine Surgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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