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
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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COMPLETED
PHASE4
35 participants
INTERVENTIONAL
2017-10-22
2020-08-07
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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midazolam delivery via intravenous
normal sedation given via Intravenous route
midazolam by nasal atomizer
midazolam
midazolam delivery via nasal atomizer
normal sedation given via nasal atomizer
intravenous midazolam
midazolam
Interventions
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midazolam by nasal atomizer
midazolam
intravenous midazolam
midazolam
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
MALE
No
Sponsors
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University of Tennessee Graduate School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jennifer Ferris, Phd
Role: STUDY_DIRECTOR
UTGSM
Locations
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UTGSM
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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UTGSMIRB1123
Identifier Type: -
Identifier Source: org_study_id
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