- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465439
Safety/Efficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
August 21, 2008 updated by: Hamilton Health Sciences Corporation
Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.
This randomized controlled trial will examine the impact of local anesthetic on the frequency of vasovagal reactions and the patients perception of pain during femoral arterial sheath removal after percutaneous coronary intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing percutaneous coronary intervention(PCI) will be randomized to receive subcutaneous local anesthetic (Lidocaine 2% without epinephrine)or no local prior to removal of femoral arterial sheath.
They will be assessed for vasovagal reactions and pain intensity during the sheath removal.The incidence of vasovagal reactions and pain intensity scores will be compared between the groups.
200 patients will be enrolled over the course of 2 months.
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
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
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 2S2
- Hamilton Health Science-Heart Investigation Unit
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Percutaneous Coronary Intervention
- Femoral arterial sheath
Exclusion Criteria:
- Less than 18 years old
- Emergency procedure
- Transferred out of heart investigation unit prior to sheath removal
- Radial or brachial sheath
- Closure devise
- Venous sheath insitu
- Intra-aortic balloon pump insitu
- Tranvenous pacing
- Mechanical ventilation
- Cognitive impairment
- Unable to read English
- Lidocaine allergy
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of vasovagal reaction during femoral sheath removal
Time Frame: During sheath removal
|
During sheath removal
|
Pain intensity during femoral sheath removal
Time Frame: During sheath removal
|
During sheath removal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Allison Cook, BScN, Hamilton Health Science
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, 2007
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
April 23, 2007
First Submitted That Met QC Criteria
April 24, 2007
First Posted (Estimate)
April 25, 2007
Study Record Updates
Last Update Posted (Estimate)
August 22, 2008
Last Update Submitted That Met QC Criteria
August 21, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Autonomic Nervous System Diseases
- Unconsciousness
- Consciousness Disorders
- Primary Dysautonomias
- Orthostatic Intolerance
- Pain
- Syncope
- Syncope, Vasovagal
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- 27071995
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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