Dilution of Verapamil During Intraarterial Administration

Study Overview
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Brief Summary
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This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups: Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL) The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.

Official Title
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Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?

Conditions
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Vasospasm;Peripheral, Burning, Pain

Intervention / Treatment
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* Drug: Verapamil
* Drug: Nicardipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria English Speaking patients who are age 18 or older Patient must be able to provide own consent and communicate with staff Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC) Exclusion Criteria Intubated or sedated patients Agitated patients requiring moderate sedation prior to TRA Patient's undergoing femoral access for the LHC Non-English speaking patients Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure <65), Bradycardia (heart rate<40) Emergent cardiac catheterization Inability to obtain radial artery access Conversion to radial artery access from another access site

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verapamil<br>Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline | Drug: Verapamil<br>* All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.<br>* Other names: Calcium channel blocker;|
| Placebo Comparator: Nicardipine<br>Intra-arterial Nicardipine 400 mcg undiluted (8mL) | Drug: Nicardipine<br>* Calcium channel blocker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial Artery Spasm | The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access. | approximately 30 minutes | 
| Pain Prior to Intra-arterial Calcium Channel Blocker Administration | Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10). | 30 seconds prior to administration | 
| Pain After Intra-arterial Calcium Channel Blocker Administration | Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10). | 30 seconds post administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac catheterization, intra-arterial calcium channel blockers, radial artery spasm