Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
- Conditions
- VasectomySedation
- Interventions
- Device: midazolam by nasal atomizer
- Registration Number
- NCT06449365
- Lead Sponsor
- University of Tennessee Graduate School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 35
- all men who request no-scalpel vasectomy procedure
- anyone not eligible for no-scalpel vasectomy procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description midazolam delivery via intravenous midazolam by nasal atomizer normal sedation given via Intravenous route midazolam delivery via nasal atomizer intravenous midazolam normal sedation given via nasal atomizer
- Primary Outcome Measures
Name Time Method Patient Questionnaire (generated by institution) 1 year comparison between groups
- Secondary Outcome Measures
Name Time Method Nursing Questionnaire (generated by institution) 1 year comparison between groups
Trial Locations
- Locations (1)
UTGSM
🇺🇸Knoxville, Tennessee, United States