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

NCT ID: NCT00686231

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Dose Test 15mg NTG

Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1

Group Type: EXPERIMENTAL

Nitroglycerin 15mg

Intervention Type: DRUG

15mg Nitroglycerin applied topically to one wrist

Placebo

Intervention Type: DRUG

Topical skin moisturizing cream with same appearance as active agent

Dose Test 30mg NTG

Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1

Group Type: EXPERIMENTAL

Nitroglycerin 30mg

Intervention Type: DRUG

30mg Nitroglycerin applied topically to one wrist

Placebo

Intervention Type: DRUG

Topical skin moisturizing cream with same appearance as active agent

Combination Test 20mg Lidocaine

Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2

Group Type: EXPERIMENTAL

Nitroglycerin 30mg

Intervention Type: DRUG

30mg Nitroglycerin applied topically to one wrist

Lidocaine 20mg

Intervention Type: DRUG

20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

Placebo

Intervention Type: DRUG

Topical skin moisturizing cream with same appearance as active agent

Combination Test 40mg Lidocaine

Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2

Group Type: EXPERIMENTAL

Nitroglycerin 30mg

Intervention Type: DRUG

30mg Nitroglycerin applied topically to one wrist

Lidocaine 40mg

Intervention Type: DRUG

40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

Placebo

Intervention Type: DRUG

Topical skin moisturizing cream with same appearance as active agent

Interventions

Nitroglycerin 15mg

15mg Nitroglycerin applied topically to one wrist

Intervention Type: DRUG

Nitroglycerin 30mg

30mg Nitroglycerin applied topically to one wrist

Intervention Type: DRUG

Lidocaine 20mg

20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

Intervention Type: DRUG

Lidocaine 40mg

40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo

Intervention Type: DRUG

Placebo

Topical skin moisturizing cream with same appearance as active agent

Intervention Type: DRUG

Other Intervention Names

skin moisturizing cream

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCSF Medical Center

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22699036 (View on PubMed)

Other Identifiers

56438-31921

Identifier Type: -

Identifier Source: org_study_id