Surgical Pleth Index versus Nociception Level Index in children under general anesthesia
Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population: An Observational Study
Radboud University Medical Center · NCT07084935
This study will test whether the NOL and SPI monitors can detect and quantify nociceptive (pain-related) responses during general anesthesia in children aged 1 to 12.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 12 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT07084935 on ClinicalTrials.gov |
What this trial studies
This single-center, prospective observational study at Radboud University Medical Center will connect pediatric patients to both the Nociception Level (NOL) index and the Surgical Pleth Index (SPI) during routine general anesthesia. After induction and baseline recording, a standardized tetanic stimulus (5 seconds, 60 mA, 100 Hz) will be applied and both monitors' responses recorded, followed by monitoring responses to clinical nociceptive events such as intubation and surgical incision. The NOL device integrates multiple physiologic signals with a learning algorithm, while SPI focuses on heart rate variability and plethysmographic amplitude, and the study will directly compare their ability to detect and quantify nociceptive stimuli. All care remains per standard anesthesia protocols and the study is non-interventional beyond connecting monitoring devices and applying the standard tetanic stimulus.
Who should consider this trial
Good fit: Children aged 1 to 12 years, ASA I–III, scheduled for elective surgery under general anesthesia at the participating center are ideal candidates.
Not a fit: Children with chronic pain or chronic analgesic use, those with adhesive allergies, or without a free limb for sensors are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a more reliable monitor to guide anesthesia and pain management in children.
How similar studies have performed: Both NOL and SPI have produced signal changes to nociceptive events in prior pediatric studies, but direct head-to-head comparisons in children remain novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female * ASA I, ASA II and ASA III * Aged 1 to 12 years old * Scheduled to undergo elective surgery with general anaesthesia Exclusion Criteria: * 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 this trial is running
Nijmegen, Gelderland
- Radboud university medical centre — Nijmegen, Gelderland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Ignacio Malagon, Professor — Radboud University Medical Center
- Study coordinator: Cees klein Tank, Drs.
- Email: cees.kleintank@radboudumc.nl
- Phone: +31 (024) 365 57 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nociceptive Pain, Anesthesia, Pediatric Anesthesia, Nociception Monitoring, Nociception monitoring, Pediatric population, NOL index, Surgical pleth index