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

NCT00686231 | Completed Phase 1 Results

• 1 other identifier: 56438-31921
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Dose Test 15mg NTG

EXPERIMENTAL

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

Drug: Nitroglycerin 15mg; Drug: Placebo

Dose Test 30mg NTG

EXPERIMENTAL

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

Drug: Nitroglycerin 30mg; Drug: Placebo

Combination Test 20mg Lidocaine

EXPERIMENTAL

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

Drug: Nitroglycerin 30mg; Drug: Lidocaine 20mg; Drug: Placebo

Combination Test 40mg Lidocaine

EXPERIMENTAL

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

Drug: Nitroglycerin 30mg; Drug: Lidocaine 40mg; Drug: Placebo

Interventions

Nitroglycerin 15mg DRUG

15mg Nitroglycerin applied topically to one wrist

Dose Test 15mg NTG

Nitroglycerin 30mg DRUG

30mg Nitroglycerin applied topically to one wrist

Combination Test 20mg Lidocaine; Combination Test 40mg Lidocaine; Dose Test 30mg NTG

Lidocaine 20mg DRUG

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

Combination Test 20mg Lidocaine

Lidocaine 40mg DRUG

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

Combination Test 40mg Lidocaine

Placebo DRUG

Topical skin moisturizing cream with same appearance as active agent

Also known as: skin moisturizing cream

Combination Test 20mg Lidocaine; Combination Test 40mg Lidocaine; Dose Test 15mg NTG; Dose Test 30mg NTG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 22699036 DERIVED

MeSH Terms

Interventions

Nitroglycerin; Lidocaine

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Andrew Boyle
• Organization: UCSF

aboyle@medicine.ucsf.edu

415-514-0827

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 29, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 6, 2020
• Results First Posted: July 22, 2010

Record last verified: 2020-03

Locations

US (1)