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Completed

NCT Number: NCT02714777

General Anesthesia and Autonomic Nervous System in Children

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).

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Key information

Conditions

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autonomic nervous system activity

Device

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

Primary outcomes

  1. Description of parasympathetic activity evolution by heart rate variability

    Time frame: 24 hours

    Parasympathetic activity evolution will be described by heart rate variability

Secondary outcomes

  1. Heart rate variability (HRV)

    Time frame: 24 hours

    HRV 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

  2. Heart rate variability (HRV)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: ANESPEDIA

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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