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

University of Tennessee Graduate School of Medicine

Status and phase: Completed; Phase 4

Conditions: Vasectomy; Sedation

Treatments: Drug: intravenous midazolam; Device: midazolam by nasal atomizer

Study type: Interventional

Funder types: Other

Identifiers

NCT06449365

UTGSMIRB1123

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all men who request no-scalpel vasectomy procedure

Exclusion criteria

• anyone not eligible for no-scalpel vasectomy procedure

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

midazolam delivery via intravenous

Active Comparator group

Description:

normal sedation given via Intravenous route

Treatment:

Device: midazolam by nasal atomizer

midazolam delivery via nasal atomizer

Active Comparator group

Description:

normal sedation given via nasal atomizer

Treatment:

Drug: intravenous midazolam