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General Anesthesia and Autonomic Nervous System in Children

General Anesthesia and Autonomic Nervous System in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02714777
Acronym
ANESPEDIA
Enrollment
45
Registered
2016-03-21
Start date
2016-06-30
Completion date
2017-03-31
Last updated
2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

General anesthesia, Autonomic nervous system, Children

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.

Interventions

Autonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Description of parasympathetic activity evolution by heart rate variability24 hoursParasympathetic activity evolution will be described by heart rate variability

Secondary

MeasureTime frameDescription
Heart rate variability (HRV)24 hoursHRV is measured by a 24H-Holter Electrocardiography (ECG). It is a composite outcome : SDNN, pNN30, pNN50, RMSSD, SD1, SD2, LF, VLF, LF/HF ratio and Ptot indexes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026