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Clinical Trials/NCT05233449
NCT05233449
Completed
Not Applicable

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

University Hospital, Lille2 sites in 1 country30 target enrollmentMarch 4, 2022
ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
University Hospital, Lille
Enrollment
30
Locations
2
Primary Endpoint
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2022
End Date
May 17, 2022
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]

Time Frame: 5 minutes after stimulation

NoL variation = \[(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)\] / \[NoL before stimulation\]

Secondary Outcomes

  • Systolic Blood Pressure (SBP) variation(5 minutes after stimulation)
  • Analgesia Nociception Index (ANI) variation(5 minutes after stimulation)

Study Sites (2)

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