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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 12
Healthy Volunteers: f
View:

• Male or female

• ASA I, ASA II and ASA III

• Aged 1 to 12 years old

• Scheduled to undergo elective surgery with general anaesthesia

Locations
Other Locations
Netherlands
Radboud university medical centre
RECRUITING
Nijmegen
Contact Information
Primary
Cees klein Tank, Drs.
cees.kleintank@radboudumc.nl
+31 (024) 365 57 55
Backup
Ignacio Malagon, Professor
ignacio.malagon@radboudumc.nl
+31 (024) 365 57 55
Time Frame
Start Date: 2025-07-04
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 40
Treatments
Patients aged 1 to 12 years undergoing surgery with general anesthesia.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov