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CompletedNCT05233449STIMNOLUpdated Dec 26, 2025

NoL Index Response to Stimulation in Anesthetized Children

An interventional study of NoL monitor and Stimulation in Anesthesia, sponsored by University Hospital, Lille. Completed at 2 sites in France. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
5 Years to 12 Years
Sex
All
01

Study summary

The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.

02

Conditions studied

  • Anesthesia

Keywords

  • General anesthesia
  • Nociception
  • Monitoring
  • Nociception level
  • NoL
03

In context

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 5-12 years
  • Elective surgery under general anesthesia
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Cardiac surgery
  • Opioid intake \< 24 hours before surgery
  • Cardiac arrhythmia
  • Pace maker
  • Pheochromocytoma
  • Anti-arrhythmic medication
  • Anticholinergic medication
  • Raynaud syndrome
  • Digital anomaly (malformative, traumatic)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Children anesthetized

    Inhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg

    Device: NoL monitor · Procedure: Stimulation

Interventions

  • DeviceNoL monitor

    NoL monitor : non invasive, adhesive digital device

  • ProcedureStimulation

    Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm

06

What researchers measure

Primary outcomes

  1. NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]

    NoL variation = \[(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)\] / \[NoL before stimulation\]

    Time frame: 5 minutes after stimulation

Secondary outcomes

  1. Systolic Blood Pressure (SBP) variation

    SBP variation = \[(Maximal SBP value in the 5 minutes following the stimulation) - (SBP before stimulation)\] / \[SBP before stimulation\]

    Time frame: 5 minutes after stimulation

  2. Analgesia Nociception Index (ANI) variation

    ANI variation = \[(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)\] / \[ANI before stimulation\]

    Time frame: 5 minutes after stimulation

07

Study locations

2 sites
  • Hopital Roger Salengro, CHU Lille
    Lille, France
  • Hu Est Parisien Site Trousseau Aphp
    Paris, France
08

References and documents

Publications

  • Chemam S, Cailliau E, Bert D, Tavernier B, Constant I, Sabourdin N. Nociception level response to calibrated stimulations in children: First assessment of the nociception level index in pediatric anesthesia. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101207. doi: 10.1016/j.accpm.2023.101207. Epub 2023 Mar 1. PubMed 36863410 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05233449
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Feb 10, 2022
Start date
Mar 4, 2022
Primary completion
May 17, 2022
Completion
May 17, 2022
Last update
Dec 26, 2025

Study contacts

Nada Sabourdin, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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