Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00686231
First received: May 19, 2008
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects to determine the effect of topical nitroglycerin on radial artery vasodilation. In the first phase of the study, which is a dose escalation study, each subject will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. The subjects will then return at a later date at which point they will receive the alternate dose on one wrist and placebo on the other. In the second phase of the study, we will randomize the same patients to a mixture of topical nitroglycerin and lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be performed as in the first study.


Condition Intervention Phase
Healthy
Drug: Nitroglycerin
Drug: Placebo
Drug: Lidocaine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]
    Diameter of radial artery


Secondary Outcome Measures:
  • To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]
    Radial artery diameter


Enrollment: 19
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Sorbolene cream
Drug: Placebo
Sorbolene cream
Experimental: Lidocaine
Lidocaine 1 inch
Drug: Lidocaine
Visit 2 lidocaine 1 inch + best dose Nitro vs Placebo + lidocaine
Experimental: Nitro
1 inch / 2 inches of Nitroglycerin applied topically to the wrist
Drug: Nitroglycerin
1 inch of Nitroglycerin vs 2 inches of Nitroglycerin

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to give written informed consent and comply with study requirements
  • Patient who speak English

Exclusion Criteria:

  • Presence or history of liver, cardiovascular, rheumatologic, cancer or renal disease.
  • Current treatment with any vasodilator therapy
  • Systolic blood pressure of less than 90 mmHg
  • History of radial artery catheterization within the previous year
  • Absence of radial artery blood flow in one or both arms
  • Pregnancy.
  • Active infection
  • Staff members of the Cardiac Catheterization Laboratory.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686231

Locations
United States, California
UCSF Medical Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686231     History of Changes
Other Study ID Numbers: 56438-31921
Study First Received: May 19, 2008
Results First Received: November 12, 2009
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation
To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization

Additional relevant MeSH terms:
Nitroglycerin
Lidocaine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on July 20, 2014