Dysrhythmias During General Anesthesia in Children

Brief Summary

Official Title: “Dysrhythmias During General Anesthesia in Children”

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

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Retrospective
  • Study Primary Completion Date: August 2005

Detailed Clinical Trial 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 1-Children receiving anesthesia
    • The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.

Outcome Measures for this Clinical Trial

Primary Measures

  • Arrhythmias During General Anesthesia in Children
    • Time Frame: July 1998 through July 2004
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Children’s Hospital of Philadelphia
  • Collaborator
    • Children’s Anesthesiology Associates, Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald S Litman, DO, Principal Investigator, Children’s Hospital of Philadelphia

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00715390