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RECRUITING
NCT07084935

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

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

1 Year - 12 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-07-04

Completion Date

2026-07-31

Last Updated

2025-07-25

Healthy Volunteers

No

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.

Locations (1)

Radboud university medical centre

Nijmegen, Gelderland, Netherlands