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Completed

NCT Number: NCT06449365

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

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

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Key information

Conditions

Vasectomy Sedation

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

UTGSM

Knoxville, Tennessee, 37920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all men who request no-scalpel vasectomy procedure

Exclusion criteria

  • anyone not eligible for no-scalpel vasectomy procedure

Treatment and study plan

midazolam by nasal atomizer

Device

midazolam

Other names: midazolam

intravenous midazolam

Drug

midazolam

Other names: midazolam

Primary outcomes

  1. Patient Questionnaire (generated by institution)

    Time frame: 1 year

    comparison between groups

Secondary outcomes

  1. Nursing Questionnaire (generated by institution)

    Time frame: 1 year

    comparison between groups

Other outcomes

  1. Surgeon Questionnaire (generated by institution)

    Time frame: 1 year

    comparison between groups

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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