NCT02714777

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 21, 2017

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

March 11, 2016

Last Update Submit

March 20, 2017

Conditions

Anesthesia, General

Keywords

General anesthesiaAutonomic nervous systemChildren

Outcome Measures

Primary Outcomes (1)

  • Description of parasympathetic activity evolution by heart rate variability

    Parasympathetic activity evolution will be described by heart rate variability

    24 hours

Secondary Outcomes (2)

  • Heart rate variability (HRV)

    24 hours

  • Heart rate variability (HRV)

    at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours

Study Arms (1)

Pediatric population from 4 to 8 years-old

Description of the Autonomic nervous system activity (parasympathetic activity)

Device: Autonomic nervous system activity

Interventions

Autonomic nervous system activityDEVICE

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

Pediatric population from 4 to 8 years-old

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

Study Officials

  • Hugues PATURAL, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 21, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

March 21, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)