NCT06449365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

February 28, 2024

Last Update Submit

June 3, 2024

Conditions

VasectomySedation

Outcome Measures

Primary Outcomes (1)

  • Patient Questionnaire (generated by institution)

    comparison between groups

    1 year

Secondary Outcomes (1)

  • Nursing Questionnaire (generated by institution)

    1 year

Other Outcomes (1)

  • Surgeon Questionnaire (generated by institution)

    1 year

Study Arms (2)

midazolam delivery via intravenous

ACTIVE COMPARATOR

normal sedation given via Intravenous route

Device: midazolam by nasal atomizer

midazolam delivery via nasal atomizer

ACTIVE COMPARATOR

normal sedation given via nasal atomizer

Drug: intravenous midazolam

Interventions

midazolam by nasal atomizerDEVICE

midazolam

Also known as: midazolam
midazolam delivery via intravenous
intravenous midazolamDRUG

midazolam

Also known as: midazolam
midazolam delivery via nasal atomizer

Eligibility Criteria

Age18 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPatient must be getting a non-scalpel vasectomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all men who request no-scalpel vasectomy procedure

You may not qualify if:

  • anyone not eligible for no-scalpel vasectomy procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTGSM

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jennifer Ferris, Phd

    UTGSM

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

June 10, 2024

Study Start

October 22, 2017

Primary Completion

August 7, 2020

Study Completion

August 7, 2020

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

All data deidentified in a central database

Locations

US(1)