Dysrhythmias During General Anesthesia in Children

NCT ID: NCT00715390

Last Updated: 2012-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Arrhythmias, Cardiac

Keywords

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Children Cardiac Arrhythmia General Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Anesthesiology Associates, Ltd.

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald S Litman, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2004-10-3923

Identifier Type: -

Identifier Source: org_study_id