Dysrhythmias During General Anesthesia in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00715390
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : March 1, 2011
Last Update Posted : December 27, 2012
Children's Anesthesiology Associates, Ltd.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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

Condition or disease
Arrhythmias, Cardiac

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.

Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dysrhythmias During General Anesthesia in Children
Study Start Date : October 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Arrhythmias During General Anesthesia in Children [ Time Frame: July 1998 through July 2004 ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00715390

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.
Principal Investigator: Ronald S Litman, DO Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT00715390     History of Changes
Other Study ID Numbers: 2004-10-3923
First Posted: July 15, 2008    Key Record Dates
Results First Posted: March 1, 2011
Last Update Posted: December 27, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Central Nervous System Depressants
Physiological Effects of Drugs