Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy

Phase 4

Completed

• Conditions: Vasectomy; Sedation
• Interventions: Device: midazolam by nasal atomizer; Drug: intravenous midazolam

• 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.

Study Timeline

• Study Start: 2017-10-22
• Primary Completion: 2020-08-07
• Study Completion: 2020-08-07
• Study First Submitted: 2024-02-28
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-10
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

• all men who request no-scalpel vasectomy procedure

Exclusion Criteria

• 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