Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot
20 maj 2026 uppdaterad av: Medasense Biometrics Ltd
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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:
- PONV
- 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
- Somnolence
- Sedation (Pasero score)
- Discharge readiness (modified Aldrete score)
- PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints
INTRAOPERATIVE
- Reduction in hemodynamic instability (hypertension, hypotensive events)
- Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine)
- Association between time spent with NOL values above 25 and PACU pain intensity ratings
WARD - up to 48 hours post surgery
- Patient reported satisfaction levels using questionnaire QR15
- Pain intensity (Time points: NRS according to the SOC))
- 48 hours post-operative opioid consumption
- Requirement for Acute Pain Service consultation
- Reduction in rescue opioid requirements
- Ketamine prescription on the ward
- Opioid prescription on the ward
- PONV medication consumption
- Clinician survey on the device
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jaime Baratta, MD
- Telefonnummer: 215-955-6161
- E-post: jaime.baratta@jefferson.edu
Studieorter
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
-
Kontakt:
- Jaime Baratta, MD
- Telefonnummer: 215-955-6161
- E-post: jaime.baratta@jefferson.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Retrospective cohort
A retrospective arm will be case matched from the hospital's EMR system.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total opioid requirement during surgery and PACU stay
Tidsram: One day
|
Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)
|
One day
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reduction in time to extubation
Tidsram: one day
|
Reduction in time to extubation measured in minutes
|
one day
|
|
Reduction in time to PACU discharge readiness
Tidsram: one day
|
Reduction in time to PACU discharge readiness measured in minutes
|
one day
|
|
Modified Aldrete Score
Tidsram: one day
|
Modified Aldrete Score (scale of 0-10)
|
one day
|
|
Reduction in PACU pain intensity rating
Tidsram: one day
|
Reduction in PACU pain intensity rating (NRS scale of 0-10 )
|
one day
|
|
Anesthesia Related Adverse Events - PONV
Tidsram: 1 day
|
PONV in PACU assessed used accepted PONV symptom scale (0-4)
|
1 day
|
|
Anesthesia Related Adverse Events in PACU - Respiratory Depression
Tidsram: one day
|
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
Tidsram: one day
|
Sedation & Somnolence using Pasero Scale (S 1-4)
|
one day
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ward recovery metrics - patient satisfaction levels
Tidsram: three days
|
Patient reported satisfaction levels using standard QoR15 questionnaire responses in the NOL arm only
|
three days
|
|
Intraoperative metrics - Hemodynamic instability
Tidsram: One day
|
Reduction in hemodynamic instability (hypertensive are MAP above 120mmHg, hypotensive events are MAP below 65mmHg)
|
One day
|
|
Intraoperative metrics - vasocative medication requirement
Tidsram: One day
|
Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) total doses in mgs.
|
One day
|
|
Ward recovery metrics - Pain Intensity
Tidsram: three days
|
Pain intensity.
Time points: NRS pain score on a scale of 0-10 , measurement frequency per hospital standard of care.
|
three days
|
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Intraoperative metrics - nociception levels during surgery
Tidsram: One day
|
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
Tidsram: three days
|
48 hours post-operative opioid consumption measured in morphine equivalents in mgs.
|
three days
|
|
Ward recovery metrics - Requirement for Acute Pain Service consultation
Tidsram: three days
|
Requirement for Acute Pain Service consultation (Y/N)
|
three days
|
|
Ward recovery metrics - reduction in rescue opioid requirements
Tidsram: three days
|
Reduction in rescue opioid requirements - morphine equivalents in mgs
|
three days
|
|
Ward recovery metrics - Ketamine requirement
Tidsram: three days
|
Ketamine prescription on the ward (mgs)
|
three days
|
|
Ward recovery metrics - Opioid requirement on the ward
Tidsram: three days
|
number of opioid prescriptions and total amount in morphine equivalents (mgs)
|
three days
|
|
Ward recovery metrics - PONV
Tidsram: three days
|
PONV medication consumption in mgs
|
three days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 maj 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 mars 2027
Studieregistreringsdatum
Först inskickad
5 maj 2026
Först inskickad som uppfyllde QC-kriterierna
20 maj 2026
Första postat (Faktisk)
27 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NOL Monitoring Spine Surgery
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
This is a pilot project and we have not envisioned working wth other centers on this project.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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