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

NCT ID: NCT06449365

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-22

Study Completion Date

2020-08-07

Brief Summary

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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

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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.

Conditions

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Vasectomy Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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midazolam delivery via intravenous

normal sedation given via Intravenous route

Group Type ACTIVE_COMPARATOR

midazolam by nasal atomizer

Intervention Type DEVICE

midazolam

midazolam delivery via nasal atomizer

normal sedation given via nasal atomizer

Group Type ACTIVE_COMPARATOR

intravenous midazolam

Intervention Type DRUG

midazolam

Interventions

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midazolam by nasal atomizer

midazolam

Intervention Type DEVICE

intravenous midazolam

midazolam

Intervention Type DRUG

Other Intervention Names

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midazolam midazolam

Eligibility Criteria

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Inclusion Criteria

* all men who request no-scalpel vasectomy procedure

Exclusion Criteria

* anyone not eligible for no-scalpel vasectomy procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Ferris, Phd

Role: STUDY_DIRECTOR

UTGSM

Locations

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UTGSM

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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UTGSMIRB1123

Identifier Type: -

Identifier Source: org_study_id

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NCT06410365 NOT_YET_RECRUITING PHASE4