Actively Recruiting

Age: 1Year - 12Years
All Genders
NCT07084935

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

Age: 1Year - 12Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Radboud university medical centre

Nijmegen, Gelderland, Netherlands, 6525 GA

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here