NoL Index Response to Stimulation in Anesthetized Children

Not Applicable

• Conditions: Anesthesia

• Registration Number: NCT05233449
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-03-04
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 = \[(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)\] / \[ANI before stimulation\]

Trial Locations

Locations (2)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France

Hu Est Parisien Site Trousseau Aphp; 🇫🇷 Paris, France