STIMNOL: NoL Index Response to Stimulation in Anesthetized Children

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05233449

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: NoL monitor Procedure: Stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Children anesthetized Inhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg	Device: NoL monitor NoL monitor : non invasive, adhesive digital device Procedure: Stimulation Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm

Arm

Intervention/Treatment

Experimental: Children anesthetized

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

Device: NoL monitor

NoL monitor : non invasive, adhesive digital device

Procedure: Stimulation

Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Nada Sabourdin, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT05233449

Other Study ID Numbers:

2021_0434
2021-A02797-34

First Posted:

Feb 10, 2022

Last Update Posted:

Mar 2, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

Study Results

No Results Posted as of Mar 2, 2022