Trial Outcomes & Findings for Dysrhythmias During General Anesthesia in Children (NCT NCT00715390)
NCT ID: NCT00715390
Last Updated: 2012-12-27
Results Overview
Recruitment status
COMPLETED
Target enrollment
234 participants
Primary outcome timeframe
July 1998 through July 2004
Results posted on
2012-12-27
Participant Flow
We performed a retrospective chart review of anesthetics administered at The Children's Hospital of Philadelphia from July 1998 through July 2004.
Excluded were patients with known arrhythmias or pro-arrhythmic conditions, patients with congenital heart disease and patients undergoing cardiac surgery or cardiac catheterization.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
234
|
|
Overall Study
Eligible
|
234
|
|
Overall Study
COMPLETED
|
234
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dysrhythmias During General Anesthesia in Children
Baseline characteristics by cohort
| Measure |
Children With Dysrhythmia Events During Anesthesia
n=234 Participants
The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
|
|---|---|
|
Age, Categorical
<=18 years
|
234 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
234 participants
n=5 Participants
|
|
Children with potential intraoperative dysrhythmias
|
234 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: July 1998 through July 2004Outcome measures
| Measure |
Children With Dysrhythmia Events During Anesthesia
n=220 Participants
The sample of patients screened will be the entire electronic anesthesia record database from 1998 until 2004 looking for subjects that have dysrhythmias.
|
|---|---|
|
Arrhythmias During General Anesthesia in Children
|
220 participants
|
Adverse Events
Children With Dysrhythmia Events During Anesthesia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ronald Litman, DO
The Children's Hospital of Philadelphia
Phone: 215-590-5091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place