NoL Index Response to Stimulation in Anesthetized Children (STIMNOL)

December 18, 2025 updated by: University Hospital, Lille

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children anesthetized
Inhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg
Device: NoL monitor
NoL monitor : non invasive, adhesive digital device
Procedure: Stimulation
Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
5 minutes after stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
5 minutes after stimulation
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]
5 minutes after stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Nada Sabourdin, MD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Actual)

May 17, 2022

Study Completion (Actual)

May 17, 2022

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021_0434
  • 2021-A02797-34 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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