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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00686231
First received: May 19, 2008
Last updated: July 17, 2013
Last verified: July 2013
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject)
Condition: Healthy
Interventions: Drug: Nitroglycerin
Drug: Placebo
Drug: Lidocaine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Sorbolene cream
Lidocaine Lidocaine 1 inch
Nitro 1 inch / 2 inches of Nitroglycerin applied topically to the wrist

Participant Flow:   Overall Study
    Placebo     Lidocaine     Nitro  
STARTED     20     20     20  
COMPLETED     20     20     20  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo Sorbolene cream
Lidocaine Lidocaine 1 inch
Nitro 1 inch / 2 inches of Nitroglycerin applied topically to the wrist
Total Total of all reporting groups

Baseline Measures
    Placebo     Lidocaine     Nitro     Total  
Number of Participants  
[units: participants]
  19     19     19     57  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     19     19     19     57  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29  ± 4     29  ± 4     29  ± 4     29  ± 4  
Gender  
[units: participants]
       
Female     13     13     13     39  
Male     6     6     6     18  
Region of Enrollment  
[units: participants]
       
United States     19     19     19     57  



  Outcome Measures

1.  Primary:   To Determine if Topical Nitroglycerin Acts to Vasodilate the Radial Artery.   [ Time Frame: November 2009 ]

2.  Secondary:   To Determine if Topical Nitroglycerin Dilates the Radial Artery in the Presence of Local Anesthetic Agents Used in Cardiac Catheterization.   [ Time Frame: November 2009 ]
Results not yet posted.   Anticipated Posting Date:   11/2009   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
a


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Boyle
Organization: UCSF
phone: 415-514-0827
e-mail: aboyle@medicine.ucsf.edu


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686231     History of Changes
Other Study ID Numbers: 56438-31921
Study First Received: May 19, 2008
Results First Received: November 12, 2009
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board