Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449365
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-02-28
Brief Title:
Comparison of Intravenous VS Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
Sponsor:
University of Tennessee Graduate School of Medicine
Organization:
University of Tennessee Graduate School of Medicine
Study Overview
Official Title:
Comparison of Intravenous VS Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Purpose This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic
Detailed Description:
Purpose This study compares administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic
Patients and methods Patients will be randomly assigned to one of two groups midazolam given via traditional intravenous route or midazolam via a nasal atomizer Outcomes are patient perception of anxiety with the drug delivery method discomfort with administration pain during the procedure and length of sedation effects Medical personnel rated ease of use efficacy time to sedation and time to transport after procedure
Patients and methods Patients will be randomly assigned to one of two groups midazolam given via traditional intravenous route or midazolam via a nasal atomizer Outcomes are patient perception of anxiety with the drug delivery method discomfort with administration pain during the procedure and length of sedation effects Medical personnel rated ease of use efficacy time to sedation and time to transport after procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None