- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04030663
The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter
The Effect of Periradial Injection of Papaverine Versus Nitroglycerine on Radial Artery Diameter Prior to Cannulation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
we want in this study to facilitate radial artery canulation and decrease the number of attemps of puncture which may lead to disappearance of the pulse.
The aim of this study is to compare the effect of adding papaverine to local anesthetic xylocaine versus adding nitroglycerine to it on the diameter and palpability of radial artery and if perioperative spasm will decrease significantly with one of these methods.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Benisuef
-
Cairo, Benisuef, Egypt, 28735
- Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who will be included in the study are those scheduled for elective cardiac surgery who are hemodynamically stable.
Exclusion Criteria:
- Any patient with negative modified Allen test, atrioventricular block, glaucoma, altered liver function, unstable hemodynamics, emergency surgeries, and peripheral vascular disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: papaverine
|
periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
|
Active Comparator: nitroglycerine
|
periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
|
Placebo Comparator: xlyocaine
|
periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diameter of radial artery
Time Frame: 20 minutes
|
after periradial injection of one of the drugs we will feel the radial artery pulse and record if there is a change in the palpatory score and mesure the diameter of the radial artery by ultrasound in cardiac surgery patients
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spasm of radial artery
Time Frame: 24 hours
|
detect if there is postoperative spasm of radial artery
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA00015574
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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