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Completed

NCT Number: NCT05625503

Dilution of Verapamil During Intraarterial Administration

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.

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Key information

Conditions

Vasospasm;Peripheral Burning Nervous System Diseases Neurologic Manifestations Pain Paresthesia Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Illinois Hospital

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verapamil

Drug

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

Other names: Calcium channel blocker

nicardipine

Drug

Calcium channel blocker

Primary outcomes

  1. Radial Artery Spasm

    Time frame: 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.

  2. Pain Prior to Intra-arterial Calcium Channel Blocker Administration

    Time frame: 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).

  3. Pain After Intra-arterial Calcium Channel Blocker Administration

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2022
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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