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Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population

NCT07084935 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-07-25

No results posted yet for this study

Summary

This observational study aims to compare two nociception monitoring methods. The Nociception Level (NOL) index and the Surgical Pleth Index (SPI) in the pediatric population during general anesthesia. While both monitors are designed to assess nociceptive responses through autonomic nervous system activity, they differ in methodology and parameters measured. The NOL index integrates multiple physiological signals using a self-learning algorithm, while SPI focuses on heart rate variability and plethysmographic amplitude. Although both have been studied individually in children, a direct comparison has not yet been conducted. This study will evaluate and compare each monitor's ability to detect and quantify nociceptive stimuli (surgical and tetanic) in children.

The investigators hypothesize that the NOL monitor and SPI monitor will both be able to quantify surgical stimuli and tetanic stimuli with monitors response to surgical stimuli \> monitors response to tetanic stimuli. However, the investigators also hypothesize that the NOL index will do this superiorly, as it utilizes a self-learning algorithm and more parameters are incorporated in its algorithm

Conditions

  • Nociceptive Pain
  • Anesthesia
  • Pediatric Anesthesia
  • Nociception Monitoring

Interventions

DEVICE

Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI)

All patients will be connected to the NOL and SPI during surgery after induction of general anesthesia.

DEVICE

All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision

All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Ignacio Malagon, Professor · Radboud University Medical Center

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-04
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084935 on ClinicalTrials.gov