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Completed

NCT Number: NCT05233449

NoL Index Response to Stimulation in Anesthetized Children

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.

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Key information

Conditions

Anesthesia

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Roger Salengro, CHU Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)

Treatment and study plan

NoL monitor

Device

NoL monitor : non invasive, adhesive digital device

Stimulation

Procedure

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

Primary outcomes

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

    Time frame: 5 minutes after stimulation

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

Secondary outcomes

  1. Systolic Blood Pressure (SBP) variation

    Time frame: 5 minutes after stimulation

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

  2. Analgesia Nociception Index (ANI) variation

    Time frame: 5 minutes after stimulation

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Nociception Level Index (NoL) Variation After Standardized Stimulation Under General Anesthesia in Children

Acronym: STIMNOL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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