Clinical Trials Directory

Trials / Completed

CompletedNCT05233449

NoL Index Response to Stimulation in Anesthetized Children

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICENoL monitorNoL monitor : non invasive, adhesive digital device
PROCEDUREStimulationStimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm

Timeline

Start date
2022-03-04
Primary completion
2022-05-17
Completion
2022-05-17
First posted
2022-02-10
Last updated
2025-12-26

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05233449. Inclusion in this directory is not an endorsement.