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
| Type | Name | Description |
|---|---|---|
| DEVICE | Autonomic nervous system activity | Autonomic 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.