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Clinical Trials/NCT00465439
NCT00465439
Completed
Not Applicable

Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal.

Hamilton Health Sciences Corporation1 site in 1 country78 target enrollmentMay 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Syncope, Vasovagal
Sponsor
Hamilton Health Sciences Corporation
Enrollment
78
Locations
1
Primary Endpoint
Incidence of vasovagal reaction during femoral sheath removal
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
September 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of vasovagal reaction during femoral sheath removal

Time Frame: During sheath removal

Pain intensity during femoral sheath removal

Time Frame: During sheath removal

Study Sites (1)

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