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NCT06449365 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06449365
Other study ID # UTGSMIRB1123
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 22, 2017
Est. completion date August 7, 2020

Study information
Verified date June 2024
Source University of Tennessee Graduate School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

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 information / eligibility
Status Completed
Enrollment 35
Est. completion date August 7, 2020
Est. primary completion date August 7, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - all men who request no-scalpel vasectomy procedure Exclusion Criteria: - anyone not eligible for no-scalpel vasectomy procedure

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• midazolam by nasal atomizer
midazolam
Drug:
• intravenous midazolam
midazolam

Locations
Country Name City State
United States UTGSM Knoxville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
University of Tennessee Graduate School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Surgeon Questionnaire (generated by institution) comparison between groups 1 year
Primary Patient Questionnaire (generated by institution) comparison between groups 1 year
Secondary Nursing Questionnaire (generated by institution) comparison between groups 1 year
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