Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465439
Status:
COMPLETED
Last Update Posted:
2008-08-22
First Post:
2007-04-23
Brief Title:
SafetyEfficacy Study of Local Anesthetic Prior to Femoral Artery Sheath Removal
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 interventionPCI will be randomized to receive subcutaneous local anesthetic Lidocaine 2 without epinephrineor no local prior to removal of femoral arterial sheath They will be assessed for vasovagal reactions and pain intensity during the sheath removalThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None