Dilution of Verapamil During Intraarterial Administration

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625503
• Other study ID #: 2022-0722
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 13, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: University of Illinois at Chicago
• Contact: Keshav R Patel, MD MS
• Phone: 734-306-3130
• Email: kpate447[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burning
• Burns
• Pain
• Vasospasm;Peripheral

Intervention

Drug:
• Verapamil
All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.
• Nicardipine
Calcium channel blocker

Locations

Country	Name	City	State
United States	University of Illinois Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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