Actively Recruiting
Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population: An Observational Study
Led by Radboud University Medical Center · Updated on 2025-07-25
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different devices that monitor nociception, or the body's response to painful stimuli, in children aged 1 to 12 years during general anesthesia. This observational study compares the Nociception Level (NOL) index, which uses a self-learning algorithm combining several physiological signals, with the Surgical Pleth Index (SPI), which measures heart rate variability and blood flow changes. Although both devices have been studied individually, this is the first direct comparison in the pediatric population to assess their ability to detect and measure surgical and tetanic pain stimuli. During surgery, children will be connected to both the NOL and SPI monitoring devices immediately after anesthesia induction. Before the surgical incision, a standardized tetanic stimulus lasting 5 seconds at 60 mA and 100 Hz will be applied to the ulnar nerve to simulate a controlled pain response. The study will record responses to various nociceptive events such as intubation, airway insertion, surgical incision, and opioid administration. After surgery, patients will be disconnected from the monitors, and post-operative pain and comfort scores, as well as analgesia use, will be documented. Participants will be evaluated throughout their surgery with continuous monitoring of heart rate, respiratory rate, blood pressure, neuromuscular activity, and brain activity using standard anesthesia protocols alongside the nociception devices. Researchers will measure changes in NOL and SPI indices during surgical and tetanic stimuli, responses to opioid and vasoactive medication, and correlate these with post-operative pain scores. The study is expected to last approximately one year and aims to provide detailed insights into how these monitors perform in real pediatric surgical settings.
CONDITIONS
Brief 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Duration of the surgical procedure
Participants will be connected to the nociception level index (NOL) and surgical pleth index (SPI) devices during surgery after induction of general anesthesia. A standardized tetanic stimulus will be applied before the start of the surgical incision to assess neuromuscular blockade and nociception levels. NOL and SPI monitor values will be recorded during surgery along with responses to nociceptive events such as intubation, airway insertion, incision, and opioid administration.
1 visit (in-person) during surgery
Duration - Until discharge from the anesthesia recovery room
After surgery, participants will be disconnected from the monitors upon arrival in the anesthesia recovery room. Post-operative pain and comfort scores as well as analgesia usage will be recorded by the researcher in the recovery room.
1 visit (in-person) in the recovery room
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.
I
Ignacio Malagon, Professor
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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