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Dysrhythmias During General Anesthesia in Children

Dysrhythmias During General Anesthesia in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00715390
Enrollment
234
Registered
2008-07-15
Start date
2004-10-31
Completion date
2006-08-31
Last updated
2012-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac

Keywords

Children, Cardiac Arrhythmia, General Anesthesia

Brief summary

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

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.

Interventions

None listed

Sponsors

Children's Anesthesiology Associates, Ltd.
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Arrhythmias During General Anesthesia in ChildrenJuly 1998 through July 2004

Countries

United States

Participant flow

Recruitment details

We performed a retrospective chart review of anesthetics administered at The Children's Hospital of Philadelphia from July 1998 through July 2004.

Pre-assignment details

Excluded were patients with known arrhythmias or pro-arrhythmic conditions, patients with congenital heart disease and patients undergoing cardiac surgery or cardiac catheterization.

Participants by arm

ArmCount
Children With Dysrhythmia Events During Anesthesia
The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
234
Total234

Baseline characteristics

CharacteristicChildren With Dysrhythmia Events During Anesthesia
Age, Categorical
<=18 years
234 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Children with potential intraoperative dysrhythmias234 participants
Region of Enrollment
United States
234 participants
Sex: Female, Male
Female
100 Participants
Sex: Female, Male
Male
134 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Arrhythmias During General Anesthesia in Children

Time frame: July 1998 through July 2004

ArmMeasureValue (NUMBER)
Children With Dysrhythmia Events During AnesthesiaArrhythmias During General Anesthesia in Children220 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026