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General Anesthesia and Autonomic Nervous System in Children (ANESPEDIA)

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ClinicalTrials.gov Identifier: NCT02714777
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Anesthesia, General Device: Autonomic nervous system activity

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.


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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: General Anesthesia and Autonomic Nervous System in Children
Actual Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : March 2017

Group/Cohort Intervention/treatment
Pediatric population from 4 to 8 years-old
Description of the Autonomic nervous system activity (parasympathetic activity)
Device: Autonomic nervous system activity
Autonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children from 4 to 8 years enjoying a scheduled surgery without any infection or trauma context and performed under general anesthesia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714777


Locations
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France
Chu Saint Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Hugues PATURAL, PhD CHU SAINT ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02714777     History of Changes
Other Study ID Numbers: 1608014
2016-A00295-46 ( Other Identifier: ANSM )
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
General anesthesia
Autonomic nervous system
Children

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs