Dilution of Verapamil During Intraarterial Administration

Early Phase 1

Completed

• Conditions: Vasospasm;Peripheral; Burning; Pain
• Interventions: Drug: Verapamil; Drug: Nicardipine

• Registration Number: NCT05625503
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-11-23
• Study Start: 2022-12-13
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verapamil	Verapamil	Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
Nicardipine	Nicardipine	Intra-arterial Nicardipine 400 mcg undiluted (8mL)

Primary Outcome Measures

Name	Time	Method
Radial Artery Spasm	approximately 30 minutes	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.
Pain Prior to Intra-arterial Calcium Channel Blocker Administration	30 seconds prior to administration	Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).
Pain After Intra-arterial Calcium Channel Blocker Administration	30 seconds post administration	Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).

Trial Locations

Locations (1)

University of Illinois Hospital; 🇺🇸 Chicago, Illinois, United States