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

March 4, 2020 updated by: University of California, San Francisco

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1
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)
Time Frame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2
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

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56438-31921

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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