VasectomyPhase 4NCT06449365
Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
A Phase 4 study testing midazolam by nasal atomizer and intravenous midazolam in people with Vasectomy and Sedation, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- What is being tested?
- midazolam by nasal atomizer and intravenous midazolam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2017to 7 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all men who request no-scalpel vasectomy procedure
Who cannot join
- anyone not eligible for no-scalpel vasectomy procedure
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.
Read the 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.
- Being tested
- midazolam by nasal atomizer, intravenous midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolam by nasal atomizerDevice
Also called midazolam
midazolam
intravenous midazolamDrug
Also called midazolam
midazolam
| Study group | Role | What they receive |
|---|---|---|
| midazolam delivery via intravenous | Active comparator | normal sedation given via Intravenous route Receives: Device: midazolam by nasal atomizer |
| midazolam delivery via nasal atomizer | Active comparator | normal sedation given via nasal atomizer Receives: Drug: intravenous midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Questionnaire (generated by institution)
comparison between groups
Measured: 1 year
Secondary outcomes (1)
Nursing Questionnaire (generated by institution)
comparison between groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start22 Oct 2017
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Ferris, Phd, Study director, UTGSM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449365
- Sponsor's protocol ID
- UTGSMIRB1123
- Status last verified
- Jun 2024
- First submitted
- 28 Feb 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data deidentified in a central database
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
- ClinicalTrials.gov ID
- NCT06449365
- Acronym / sponsor ID
- UTGSMIRB1123
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Study start
- 22 Oct 2017 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control
| Arm | Type | Receives |
|---|---|---|
| midazolam delivery via intravenous | Active comparator | Device: midazolam by nasal atomizernormal sedation given via Intravenous route |
| midazolam delivery via nasal atomizer | Active comparator | Drug: intravenous midazolamnormal sedation given via nasal atomizer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all men who request no-scalpel vasectomy procedure
Key exclusion criteria (1 listed)
- anyone not eligible for no-scalpel vasectomy procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midazolam by nasal atomizerAlso: midazolammidazolam | Device | midazolam delivery via intravenous |
| intravenous midazolamAlso: midazolammidazolam | Drug | midazolam delivery via nasal atomizer |
Primary outcome
Patient Questionnaire (generated by institution)
Time frame: 1 year
comparison between groups
1 secondary outcome
Nursing Questionnaire (generated by institution)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No. All data deidentified in a central database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Ferris, Phd study director
UTGSM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing midazolam by nasal atomizer and intravenous midazolam in people with Vasectomy and Sedation, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Questionnaire (generated by institution) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.