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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02797-34 | Other Identifier | ID-RCB number, ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children anesthetized | Experimental | Inhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NoL monitor | Device | NoL monitor : non invasive, adhesive digital device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Analgesia Nociception Index (ANI) variation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada Sabourdin, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Roger Salengro, CHU Lille | Lille | France | ||||
| Hu Est Parisien Site Trousseau Aphp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36863410 | Result | 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. |
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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.
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| Stimulation |
| Procedure |
Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm |
|
ANI variation = [(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)] / [ANI before stimulation] |
| 5 minutes after stimulation |
| Paris |
| France |