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NCT02652117 Clinical Trial

Regional Anesthesia in Cardiac Pediatric Patients Less Than 5 Years Old

Anesthesia Clinical Trial

Official title:
Retrospective Review of Regional Anesthesia in Cardiac Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02652117
Other study ID # 201212725
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2007
Est. completion date July 2013

Study information
Verified date May 2023
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia.

Description:

Intra-operative anesthesia medical records of pediatric patients undergoing cardiac surgery will be acquired from July 2007 to July 2013. Allocation of regional anesthesia, and the use of spinal versus epidural versus epidural with catheter administration will be determined by provider preference. Date of surgery, age in months, gender, type of surgery, type of anesthesia, regional drugs, PaCO2 upon arrival in the PICU, time to extubation, and reintubation if applicable will be recorded. Time to extubation will be categorized into within the OR, less than 24 hours, or greater than or equal to 24 hours. PaCO2 levels will be categorized into hypercarbia (PaCO2 ≥ 50mmHg) and normal (PaCO2 < 50mmHg).

Recruitment information / eligibility
Status Completed
Enrollment 545
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 59 Months
Eligibility Inclusion Criteria: - Must be pediatric patients undergoing cardiac surgery under the age of 5 years old between the years 2007 and 2013 Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Iowa

References & Publications (2)

Fawcett WJ, Edwards RE, Quinn AC, MacDonald IA, Hall GM. Thoracic epidural analgesia started after cardiopulmonary bypass. Adrenergic, cardiovascular and respiratory sequelae. Anaesthesia. 1997 Apr;52(4):294-9. doi: 10.1111/j.1365-2044.1997.80-az0088.x. — View Citation

Liu S, Carpenter RL, Neal JM. Epidural anesthesia and analgesia. Their role in postoperative outcome. Anesthesiology. 1995 Jun;82(6):1474-506. doi: 10.1097/00000542-199506000-00019. No abstract available. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To expect difference in time to extubation 24 hours
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