Anesthesia Clinical Trial
Official title:
Double-Blind, Randomized, Controlled Trial, Small Volume Bolus of Papaverine Versus Heparin to Maintain Patency of Peripheral Arterial Catheters in Pediatric Patients Undergoing Surgical Procedures: Pilot Study
Verified date | October 2022 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare intraoperative papaverine plus heparin to heparin alone for prevention of arterial spasm and maintenance of patency of peripheral arterial catheters during surgery in pediatric patients. The hypothesis is that periodic, intraoperative small-volume boluses of diluted papaverine plus heparin in peripheral arterial catheters of pediatric patients will prevent arterial spasm and help maintain patency of arterial catheters during general anesthesia.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 10, 2020 |
Est. primary completion date | October 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility | Inclusion Criteria: - All patients age 0-17 years who would require elective placements of arterial catheters based on patients clinical complexity (ex. congenital heart disease) or based on the type of surgery (ex. open heart surgery). Exclusion Criteria: - Patients with a history of significant liver dysfunction. - Patients undergoing liver transplants. - Patients with Grade 2 or more of intraventricular hemorrhage. - All preterm patients with a gestational age less than 37 weeks at the time of surgery. |
Country | Name | City | State |
---|---|---|---|
United States | UT Health | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Optimal Arterial Waveform | Optimal waveform was defined as easy aspiration of a blood sample (negative aspiration is easy and draws back freely without cavitation, and takes no more than 30 seconds to draw 1 mL), absence of color change at the catheter insertion site, and presence of a dicrotic notch in the arterial pressure waveform (a distinct dicrotic notch implies system has good resolution at higher frequencies and is not overdamped). | 5 minutes after first dose | |
Secondary | Number of Participants With Optimal Arterial Waveform | Optimal waveform was defined as easy aspiration of a blood sample (negative aspiration is easy and draws back freely without cavitation, and takes no more than 30 seconds to draw 1 mL), absence of color change at the catheter insertion site, and presence of a dicrotic notch in the arterial pressure waveform (a distinct dicrotic notch implies system has good resolution at higher frequencies and is not overdamped). | 60 minutes after first dose | |
Secondary | Number of Participants With Suboptimal Waveforms Who Received Rescue Papaverine and for Whom Papaverine Rescued Suboptimal Waveforms | These data were collected only from participants who received rescue papaverine. 7 in the Papaverine plus Heparin arm received rescue papaverine. 17 in the Heparin arm received rescue papaverine. | 5 minutes after injection of rescue papaverine (about 70 minutes after first study drug dose and about 10 minutes after second study drug dose) |
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