NoL Index Response to Stimulation in Anesthetized Children (STIMNOL)

University Hospital, Lille

Status: Completed

Conditions: Anesthesia

Treatments: Device: NoL monitor; Procedure: Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05233449

2021_0434

2021-A02797-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Children anesthetized

Experimental group

Description:

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

Treatment:

Procedure: Stimulation

Device: NoL monitor