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NCT07084935: NOLvsSPI
Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population
trial testing Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI) in Nociceptive Pain in 40 participants. Currently enrolling.
31 July 2026
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 4 July 2025 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI)
- All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision
Conditions studied
- Nociceptive Pain — all drugs for Nociceptive Pain →
- Anesthesia — all drugs for Anesthesia →
- Pediatric Anesthesia — all drugs for Pediatric Anesthesia →
- Nociception Monitoring — all drugs for Nociception Monitoring →
Sponsor
Radboud University Medical Center
Who can join
Adults 1 to 12, any sex, with Nociceptive Pain or Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07084935
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07084935 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
- Last refreshed: 25 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07084935.
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