General Anesthesia and Autonomic Nervous System in Children

Completed

• Conditions: Anesthesia, General
• Interventions: Device: Autonomic nervous system activity

• Registration Number: NCT02714777
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to 8 years old) receiving elective surgery, the impact of general anesthesia on autonomic nervous system and their kinetics of early postoperative course (24 hours).

Detailed Description

Some physiological factors such as sport activity or pathological as sepsis, certain chronic diseases or diabetes are known to modulate the overall autonomic activity and the intrinsic capacity of the individual to regulate its sympathovagal balance. These influences can alter the physiological autonomic balance sometimes with positive consequences on the Cardiac frequency-breathing control, blood pressure adjustment depending on the position of the individual, on the status of blood volume, but sometimes deleterious with bad regulation of sinus cardiac activity and respiration rate.

General anesthesia is recognized as one of the factors that can modify more or less sustainable the sympathovagal autonomic balance. While many studies described the effects of anesthesia on the autonomic nervous system, most data are done in adult subjects. For the child who sees intrinsically autonomic physiological changes related to its maturative status, assessment of the impact of anesthesia in the pediatric population in per and postoperative was never realized.

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-21
• Status Verified: 2016-05
• Study Start: 2016-06
• Primary Completion: 2016-11
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Post-anesthesia Monitoring in pediatric intensive care units or Pediatric Surgery Hospital North of Saint Etienne.
• Compendium of the form signed by the holder of parental authority

Exclusion Criteria

• Child with pathologies reaching the central nervous system or the brain stem.
• Children with a severe pathology of cardio-respiratory or heart being referred to treatment.
• Children requiring emergency surgery or trauma or septic or inflammatory context

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric population from 4 to 8 years-old	Autonomic nervous system activity	Description of the Autonomic nervous system activity (parasympathetic activity)

Primary Outcome Measures

Name	Time	Method
Description of parasympathetic activity evolution by heart rate variability	24 hours	Parasympathetic activity evolution will be described by heart rate variability

Secondary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours	HRV is measured by a 24H-Holter Electrocardiography (ECG). It is a composite outcome : HF, SDNN, pNN30, pNN50, RMSSD, SD1, SD2, LF, VLF, LF/HF ratio and Ptot indexes

Trial Locations

Locations (1)

Chu Saint Etienne; 🇫🇷 Saint Etienne, France