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

June 3, 2024 updated by: University of Tennessee Graduate School of Medicine
Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • UTGSM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all men who request no-scalpel vasectomy procedure

Exclusion Criteria:

  • anyone not eligible for no-scalpel vasectomy procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: midazolam delivery via intravenous
normal sedation given via Intravenous route
Device: midazolam by nasal atomizer
midazolam
Other Names:
  • midazolam
Active Comparator: midazolam delivery via nasal atomizer
normal sedation given via nasal atomizer
Drug: intravenous midazolam
midazolam
Other Names:
  • midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Questionnaire (generated by institution)
Time Frame: 1 year
comparison between groups
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nursing Questionnaire (generated by institution)
Time Frame: 1 year
comparison between groups
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon Questionnaire (generated by institution)
Time Frame: 1 year
comparison between groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee Graduate School of Medicine

Investigators

  • Study Director: Jennifer Ferris, Phd, UTGSM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2017

Primary Completion (Actual)

August 7, 2020

Study Completion (Actual)

August 7, 2020

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTGSMIRB1123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data deidentified in a central database

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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