Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population
Recruiting now
Conditions studied: Nociceptive Pain, Anesthesia, Pediatric Anesthesia, Nociception Monitoring
In brief
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
Key facts
- Study ID
- NCT07084935
- Run by
- Radboud University Medical Center
- People needed
- 40
- Starts
- 2025-07-04
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2025-07-25
Who can join
Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- Radboud university medical centre — Nijmegen, Gelderland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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