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Dilution of Verapamil During Intraarterial Administration

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05625503
Enrollment
55
Registered
2022-11-23
Start date
2022-12-13
Completion date
2023-12-01
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning, Pain, Vasospasm;Peripheral

Keywords

cardiac catheterization, intra-arterial calcium channel blockers, radial artery spasm

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.

Interventions

DRUGVerapamil

All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.

DRUGNicardipine

Calcium channel blocker

Sponsors

University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radial Artery Spasmapproximately 30 minutesThe 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 Administration30 seconds prior to administrationPain 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 Administration30 seconds post administrationPain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026