Dysrhythmias During General Anesthesia in Children

This study has been completed.
Sponsor:
Collaborator:
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00715390
First received: July 11, 2008
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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


Condition
Arrhythmias, Cardiac

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dysrhythmias During General Anesthesia in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Arrhythmias During General Anesthesia in Children [ Time Frame: July 1998 through July 2004 ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: October 2004
Study Completion Date: August 2006
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All patients who have undergone anesthesia at the Children's Hospital of Philadelphia or at one of CHOP's satellite surgicenters, and whose anesthetic record was recorded electronically into the Compurecord system will be screened.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715390

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Anesthesiology Associates, Ltd.
Investigators
Principal Investigator: Ronald S Litman, DO Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00715390     History of Changes
Other Study ID Numbers: 2004-10-3923
Study First Received: July 11, 2008
Results First Received: April 3, 2009
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Children
Cardiac Arrhythmia
General Anesthesia

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014