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| Sponsored by: |
Hamilton Health Sciences |
| Information provided by: | Hamilton Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00465439 |
Purpose
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.
| Condition | Intervention |
|
Syncope, Vasovagal Pain Intensity |
Drug: Subcutaneous Lidocaine 2% (Xylocaine) without epinephrine |
| MedlinePlus related topics: | Anesthesia Fainting |
| ChemIDplus related topics: | Lidocaine Epinephrine Epinephrine bitartrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized Controlled Trial Examining the Effect of Subcutaneous Xylocaine 2% on the Incidence of Vasovagal Reactions and Pain Intensity During Femoral Artery Sheath Removal. |
| Enrollment: | 78 |
| Study Start Date: | May 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |||||
| Hamilton Health Science-Heart Investigation Unit | |||||
| Hamilton, Ontario, Canada, L8N 2S2 | |||||
| Hamilton Health Sciences |
| Principal Investigator: | Allison Cook, BScN | Hamilton Health Science |
More Information
| Responsible Party: | Hamilton Health Science ( A Cook ) |
| Study ID Numbers: | 27071995 |
| First Received: | April 23, 2007 |
| Last Updated: | August 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00465439 |
| Health Authority: | Canada: Ethics Review Committee |
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