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RecruitingNCT07084935

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

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Trial Parameters

ConditionNociceptive Pain
SponsorRadboud University Medical Center
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment40
SexALL
Min Age1 Year
Max Age12 Years
Start Date2025-07-04
Completion2026-07-31
Interventions
Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI)All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision

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Brief 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

Eligibility Criteria

Inclusion Criteria: * Male or female * ASA I, ASA II and ASA III * Aged 1 to 12 years old * Scheduled to undergo elective surgery with general anaesthesia Exclusion Criteria: * Patients with chronic pain * Patients with chronic analgesia usage. * Known allergy to the adhesives used in the sensors. * No free available limb to attach the probes to.

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