Vasectomy, Sedation
Conditions
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.
Interventions
DEVICEmidazolam by nasal atomizer
midazolam
midazolam
Sponsors
University of Tennessee Graduate School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
randomized control
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* all men who request no-scalpel vasectomy procedure
Exclusion criteria
* anyone not eligible for no-scalpel vasectomy procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Questionnaire (generated by institution) | 1 year | comparison between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nursing Questionnaire (generated by institution) | 1 year | comparison between groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Questionnaire (generated by institution) | 1 year | comparison between groups |
Countries
United States
Outcome results
None listed