Dysrhythmias During General Anesthesia in Children

Arrhythmias, Cardiac Clinical Trial

Official title:

Dysrhythmias During General Anesthesia in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715390
• Other study ID #: 2004-10-3923
• 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

• Arrhythmias, Cardiac

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