Dilution of Verapamil During Intraarterial Administration

University of Illinois

Status and phase: Completed; Early Phase 1

Conditions: Burning; Pain; Vasospasm;Peripheral

Treatments: Drug: Nicardipine; Drug: Verapamil

Study type: Interventional

Funder types: Other

Identifiers

NCT05625503

2022-0722

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups, including a placebo group

Verapamil

Active Comparator group

Description:

Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline

Treatment:

Drug: Verapamil

Nicardipine

Placebo Comparator group

Description:

Intra-arterial Nicardipine 400 mcg undiluted (8mL)

Treatment:

Drug: Nicardipine