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

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

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 in 2 visits to determine the effect of topical nitroglycerin on radial artery vasodilation. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nitroglycerin 15mg; Drug: Placebo; Drug: Nitroglycerin 30mg; Drug: Lidocaine 20mg; Drug: Lidocaine 40mg

Detailed Description

During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second study visit, the same participants will be randomly assigned to one of two Combination-Test arms to receive bilateral topical application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist. Measurements of radial artery diameter will be performed as in the first visit.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Test 15mg NTG; Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1	Drug: Nitroglycerin 15mg; 15mg Nitroglycerin applied topically to one wrist; Drug: Placebo; Topical skin moisturizing cream with same appearance as active agent; Other Names: skin moisturizing cream
Experimental: Dose Test 30mg NTG; Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1	Drug: Placebo; Topical skin moisturizing cream with same appearance as active agent; Other Names: skin moisturizing cream; Drug: Nitroglycerin 30mg; 30mg Nitroglycerin applied topically to one wrist
Experimental: Combination Test 20mg Lidocaine; Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2	Drug: Placebo; Topical skin moisturizing cream with same appearance as active agent; Other Names: skin moisturizing cream; Drug: Nitroglycerin 30mg; 30mg Nitroglycerin applied topically to one wrist; Drug: Lidocaine 20mg; 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo
Experimental: Combination Test 40mg Lidocaine; Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2	Drug: Placebo; Topical skin moisturizing cream with same appearance as active agent; Other Names: skin moisturizing cream; Drug: Nitroglycerin 30mg; 30mg Nitroglycerin applied topically to one wrist; Drug: Lidocaine 40mg; 40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin	Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process.	Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1
Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)	Radial artery diameter was measured with ultrasonography using a high-frequency (13 MHz) linear array transducer 2 cm proximal to the radial styloid process. To compare combination of (Lidocaine + Nitroglycerin) or (Lidocaine + placebo), at visit 2, participants randomized to Comparison A received 30mg NTG + 20mg Lidocaine on one wrist, and placebo + 20mg Lidocaine on the other wrist; participants randomized to Comparison B received 30mg Nitroglycerin + 40mg Lidocaine on one wrist, and placebo + 40mg Lidocaine on the other wrist.	Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Publications and helpful links

General Publications

• Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 19, 2008
• First Submitted That Met QC Criteria: May 28, 2008
• First Posted (Estimate): May 29, 2008

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: 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: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Nitroglycerin
• Other Study ID Numbers: 56438-31921