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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00715390
Other study ID # 2004-10-3923
Secondary ID
Status Completed
Phase N/A
First received July 11, 2008
Last updated December 13, 2012
Start date October 2004
Est. completion date August 2006

Study information

Verified date December 2012
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in the present anesthesia environment.


Description:

It is unclear what the current state of anesthesia associated dysrhythmias is in the pediatric population. This was last investigated retrospectively in 1992 when the predominant volatile agent used for inhalation induction was halothane. Sevoflurane was approved by the Food and Drug Administration in 1995. Since that time, Sevoflurane has displaced halothane as the agent of choice for inhalation induction and has relegated halothane to be used in a narrow niche which primarily involves patients with very specific congenital heart diseases. It has been described that halothane has a larger proarrhythmic effect than sevoflurane for ventricular dysrhythmias. With the transition from the halothane to the sevoflurane era, a reassessment of the incidence and types of dysrhythmias occurring in non-cardiac pediatric patients is important.


Recruitment information / eligibility

Status Completed
Enrollment 234
Est. completion date August 2006
Est. primary completion date August 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

Children, while under anesthesia, having

1. circumstances of tachycardia and bradycardia,

2. administration of medications used in the treatment of dysrhythmias,

3. the commentary which includes comment about the heart rhythm or therapy for dysrhythmia,

4. in the quality assurance database for evidence of dysrhythmia

Exclusion Criteria:

Children with a known pre-operative:

1. prior history of dysrhythmia and/or

2. residual congenital heart disease

3. anti/pro dysrhythmic medications

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Children's Anesthesiology Associates, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arrhythmias During General Anesthesia in Children July 1998 through July 2004 No
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