Dilution of Verapamil During Intraarterial Administration

Early Phase 1CompletedNCT05625503

University of Illinois at Chicago55 enrolled

Overview

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: 1. Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Vasospasm;Peripheral Burning Pain

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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).

Time frame: 30 seconds post administration