RecruitingNCT07084935

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

Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population: An Observational Study


Sponsor

Radboud University Medical Center

Enrollment

40 participants

Start Date

Jul 4, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 YearMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision and a medical device called Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI) for people with anesthesia, nociception monitoring, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEConnecting 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.

DEVICEAll 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.


Locations(1)

Radboud university medical centre

Nijmegen, Gelderland, Netherlands

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NCT07084935


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