Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Study Overview
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Brief Summary
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Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group). Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.

Official Title
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Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs.

Conditions
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Cardiac Catheterisation

Intervention / Treatment
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* Drug: Nitroglycerin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for cardiac catheterization Suitable candidates for transradial approach Exclusion Criteria: AMI Intubated patients Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke) Prior inclusion in this trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (saline solution 10 ml) in radial artery after sheath insertion | Other: Placebo<br>* Placebo (saline solution 10 ml) in radial artery after sheath insertion<br>* Other names: Saline solution;|
| Experimental: Intervention<br>Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion | Drug: Nitroglycerin<br>* Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion<br>* Other names: Tridil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment Using Visual Analogue Scale | the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain. | Five minutes after sheath removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Duration | Procedure duration, from artery catheterization up to removal of sheath. | Immediate | 
| Radiation Exposure | Total radiation required to complete the procedure. | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial Spasm