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
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).
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).

Trial Locations

Locations (1)

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