Dysrhythmias During General Anesthesia in Children
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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 |
- 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 |
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
- circumstances of tachycardia and bradycardia,
- administration of medications used in the treatment of dysrhythmias,
- the commentary which includes comment about the heart rhythm or therapy for dysrhythmia,
- in the quality assurance database for evidence of dysrhythmia
Exclusion Criteria:
Children with a known pre-operative:
- prior history of dysrhythmia and/or
- residual congenital heart disease
- anti/pro dysrhythmic medications
Contacts and Locations| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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 May 22, 2013