Comparison of Intravenous V/S Nasal Atomizer Delivery of... | NCT06449365

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2017Actual

Primary Completion Date

Aug 7, 2020Actual

Completion Date

Aug 7, 2020Actual

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Jun 3, 2024

First Posted Date

Jun 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2024

Last Update Posted Date

Jun 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
midazolam by nasal atomizer	Device	midazolam	midazolam delivery via intravenous

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all men who request no-scalpel vasectomy procedure

Exclusion Criteria:

anyone not eligible for no-scalpel vasectomy procedure

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Patient must be getting a non-scalpel vasectomy

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Ferris, Phd	UTGSM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UTGSM		Knoxville	Tennessee	37920	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

All data deidentified in a central database

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds