Anesthesia
Conditions
Keywords
General anesthesia, Nociception, Monitoring, Nociception level, NoL
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.
Interventions
DEVICENoL monitor
NoL monitor : non invasive, adhesive digital device
PROCEDUREStimulation
Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation] | 5 minutes after stimulation | NoL variation = \[(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)\] / \[NoL before stimulation\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) variation | 5 minutes after stimulation | SBP variation = \[(Maximal SBP value in the 5 minutes following the stimulation) - (SBP before stimulation)\] / \[SBP before stimulation\] |
| Analgesia Nociception Index (ANI) variation | 5 minutes after stimulation | ANI variation = \[(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)\] / \[ANI before stimulation\] |
Countries
France
Outcome results
None listed