General Anesthesia and Autonomic Nervous System in Children

Anesthesia, General Clinical Trial

— ANESPEDIA  

Official title:

General Anesthesia and Autonomic Nervous System in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714777
• Other study ID #: 1608014
• Secondary ID: 2016-A00295-46
• Status: Completed
• Phase: N/A
• First received: March 11, 2016
• Last updated: March 20, 2017
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of parasympathetic activity evolution by heart rate variability	Parasympathetic activity evolution will be described by heart rate variability	24 hours
Secondary	Heart rate variability (HRV)	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	24 hours
Secondary	Heart rate variability (HRV)	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	at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours