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NCT05233449 Clinical Trial

NoL Index Response to Stimulation in Anesthetized Children

Anesthesia Clinical Trial

— STIMNOL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05233449
Other study ID # 2021_0434
Secondary ID 2021-A02797-34
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2022
Est. completion date July 2023

Study information
Verified date January 2022
Source University Hospital, Lille
Contact Nada Sabourdin, MD
Phone 0320445962
Email nada.sabourdin@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• NoL monitor
NoL monitor : non invasive, adhesive digital device
Procedure:
• Stimulation
Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm

Locations
Country Name City State
France Hopital Roger Salengro, CHU Lille Lille
France Hu Est Parisien Site Trousseau Aphp Paris

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Systolic Blood Pressure (SBP) variation SBP variation = [(Maximal SBP value in the 5 minutes following the stimulation) - (SBP before stimulation)] / [SBP before stimulation] 5 minutes after stimulation
Secondary Analgesia Nociception Index (ANI) variation ANI variation = [(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)] / [ANI before stimulation] 5 minutes after stimulation
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