NoL Index Response to Stimulation in Anesthetized Children

NCT05233449 | Completed

• 2 other identifiers: 2021_04342021-A02797-34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anesthesia

Keywords

General anesthesia; Nociception; Monitoring; Nociception level; NoL

Outcome Measures

Primary Outcomes (1)

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

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

  5 minutes after stimulation

Secondary Outcomes (2)

• Systolic Blood Pressure (SBP) variation

  5 minutes after stimulation

• Analgesia Nociception Index (ANI) variation

  5 minutes after stimulation

Study Arms (1)

Children anesthetized

EXPERIMENTAL

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

Device: NoL monitor; Procedure: Stimulation

Interventions

NoL monitor DEVICE

NoL monitor : non invasive, adhesive digital device

Children anesthetized

Stimulation PROCEDURE

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

Children anesthetized

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Hopital Roger Salengro, CHU Lille

Lille, France

Location

Hu Est Parisien Site Trousseau Aphp

Paris, France

Location

Related Publications (1)

• 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.

  PMID: 36863410 RESULT

Study Officials

• Nada Sabourdin, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In order to avoid the bias related to the order of the stimuli, the order of application of the stimuli will be randomized according to a Latin square of order 3.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: March 4, 2022
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (2)