Clinical Trials Directory

Trials / Completed

CompletedNCT02714777

General Anesthesia and Autonomic Nervous System in Children

Status
Completed
Phase
Study type
Observational
Enrollment
45 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
4 Years – 8 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2016-06-01
Primary completion
2016-11-01
Completion
2017-03-01
First posted
2016-03-21
Last updated
2017-03-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02714777. Inclusion in this directory is not an endorsement.