Clinical trial NCT00686231: Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Official title: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Percent Change in Diameter of Radial Artery as a Dose Test for Nitroglycerin
timeFrame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 1
measure: Percent Change From Baseline in Radial Artery Diameter to Compare Combination of Nitroglycerin or Placebo and Lidocaine (20mg or 40mg)
timeFrame: Baseline, 10 minutes, 30 minutes, 60 minutes, and 120 minutes after topical application at Visit 2
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
Study officials:
References:
citation: 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.