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

20. mai 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Retrospective cohort
A retrospective arm will be case matched from the hospital's EMR system.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total opioid requirement during surgery and PACU stay
Tidsramme: One day
Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs)
One day

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduction in time to extubation
Tidsramme: one day
Reduction in time to extubation measured in minutes
one day
Reduction in time to PACU discharge readiness
Tidsramme: one day
Reduction in time to PACU discharge readiness measured in minutes
one day
Modified Aldrete Score
Tidsramme: one day
Modified Aldrete Score (scale of 0-10)
one day
Reduction in PACU pain intensity rating
Tidsramme: one day
Reduction in PACU pain intensity rating (NRS scale of 0-10 )
one day
Anesthesia Related Adverse Events - PONV
Tidsramme: 1 day
PONV in PACU assessed used accepted PONV symptom scale (0-4)
1 day
Anesthesia Related Adverse Events in PACU - Respiratory Depression
Tidsramme: 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
Tidsramme: one day
Sedation & Somnolence using Pasero Scale (S 1-4)
one day

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ward recovery metrics - patient satisfaction levels
Tidsramme: three days
Patient reported satisfaction levels using standard QoR15 questionnaire responses in the NOL arm only
three days
Intraoperative metrics - Hemodynamic instability
Tidsramme: One day
Reduction in hemodynamic instability (hypertensive are MAP above 120mmHg, hypotensive events are MAP below 65mmHg)
One day
Intraoperative metrics - vasocative medication requirement
Tidsramme: One day
Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) total doses in mgs.
One day
Ward recovery metrics - Pain Intensity
Tidsramme: three days
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: three days
Requirement for Acute Pain Service consultation (Y/N)
three days
Ward recovery metrics - reduction in rescue opioid requirements
Tidsramme: three days
Reduction in rescue opioid requirements - morphine equivalents in mgs
three days
Ward recovery metrics - Ketamine requirement
Tidsramme: three days
Ketamine prescription on the ward (mgs)
three days
Ward recovery metrics - Opioid requirement on the ward
Tidsramme: three days
number of opioid prescriptions and total amount in morphine equivalents (mgs)
three days
Ward recovery metrics - PONV
Tidsramme: three days
PONV medication consumption in mgs
three days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medasense Biometrics Ltd

Samarbeidspartnere

Thomas Jefferson Health

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

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Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NOL Monitoring Spine Surgery

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

This is a pilot project and we have not envisioned working wth other centers on this project.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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