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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00295-46 | Other Identifier | ANSM |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric population from 4 to 8 years-old | Description of the Autonomic nervous system activity (parasympathetic activity) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic nervous system activity | Device | Autonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Description of parasympathetic activity evolution by heart rate variability | Parasympathetic activity evolution will be described by heart rate variability | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Heart rate variability (HRV) |
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Inclusion Criteria:
Exclusion Criteria:
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Children from 4 to 8 years enjoying a scheduled surgery without any infection or trauma context and performed under general anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| Hugues PATURAL, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint Etienne | Saint-Etienne | 42055 | France |
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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 |