Anesthesia, GeneralANESPEDIANCT02714777
General Anesthesia and Autonomic Nervous System in Children
An observational study of Anesthesia, General, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Autonomic nervous system activity
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children from 4 to 8 years enjoying a scheduled surgery without any infection or trauma context and performed under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Anesthesia, General
- Being tested
- Autonomic nervous system activity
- Keywords
- General anesthesia, Autonomic nervous system, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic nervous system activityDevice
Autonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative
| Study group | Role | What they receive |
|---|---|---|
| Pediatric population from 4 to 8 years-old | Description of the Autonomic nervous system activity (parasympathetic activity) Receives: Device: Autonomic nervous system activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of parasympathetic activity evolution by heart rate variability
Parasympathetic activity evolution will be described by heart rate variability
Measured: 24 hours
Secondary outcomes (2)
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
Measured: 24 hours
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
Measured: at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714777
- Sponsor's protocol ID
- 1608014
- Other IDs
- 2016-A00295-46
- Acronym
- ANESPEDIA
- Status last verified
- May 2016
- First submitted
- 11 Mar 2016
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia and Autonomic Nervous System in Children
- ClinicalTrials.gov ID
- NCT02714777
- Acronym / sponsor ID
- ANESPEDIA / 1608014
- Conditions
- Anesthesia, General
- Keywords
- General anesthesia, Autonomic nervous system, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric population from 4 to 8 years-old | – | Device: Autonomic nervous system activityDescription of the Autonomic nervous system activity (parasympathetic activity) |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 4 to 8 years enjoying a scheduled surgery without any infection or trauma context and performed under general anesthesia
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomic nervous system activityAutonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative | Device | Pediatric population from 4 to 8 years-old |
Primary outcome
Description of parasympathetic activity evolution by heart rate variability
Time frame: 24 hours
Parasympathetic activity evolution will be described by heart rate variability
2 secondary outcomes
Heart rate variability (HRV)
Time frame: 24 hours
Heart rate variability (HRV)
Time frame: at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues PATURAL, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of parasympathetic activity evolution by heart rate variability (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.