Actively Recruiting
Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population
Led by Radboud University Medical Center · Updated on 2025-07-25
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- ASA I, ASA II and ASA III
- Aged 1 to 12 years old
- Scheduled to undergo elective surgery with general anaesthesia
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radboud university medical centre
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
Research Team
C
Cees klein Tank, Drs.
CONTACT
I
Ignacio Malagon, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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