Clinical Trials Logo
  1. Home
  2. Sedation
  3. NCT06449365
  4. Details
NCT06449365 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06449365
Other study ID # UTGSMIRB1123
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 22, 2017
Est. completion date August 7, 2020

Study information
Verified date June 2024
Source University of Tennessee Graduate School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date August 7, 2020
Est. primary completion date August 7, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - all men who request no-scalpel vasectomy procedure Exclusion Criteria: - anyone not eligible for no-scalpel vasectomy procedure

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• midazolam by nasal atomizer
midazolam
Drug:
• intravenous midazolam
midazolam

Locations
Country Name City State
United States UTGSM Knoxville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
University of Tennessee Graduate School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Surgeon Questionnaire (generated by institution) comparison between groups 1 year
Primary Patient Questionnaire (generated by institution) comparison between groups 1 year
Secondary Nursing Questionnaire (generated by institution) comparison between groups 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT03399019 - Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia N/A
Completed NCT03220880 - Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
Recruiting NCT04820205 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children N/A
Recruiting NCT04549623 - End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography N/A
Recruiting NCT04822064 - Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation N/A
Completed NCT01527903 - A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit Phase 4
Completed NCT01001533 - Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation N/A
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00158873 - Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects Phase 4
Terminated NCT00205517 - Sedation and Psychopharmacology in Critical Care N/A
Recruiting NCT04096768 - The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation Phase 3
Active, not recruiting NCT05082623 - The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters N/A
Suspended NCT03285165 - Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients Phase 2/Phase 3
Active, not recruiting NCT04788589 - Sedation and Ventilator Weaning Protocol in PICU N/A
Completed NCT03425474 - Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy Phase 3
Recruiting NCT06061159 - The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction Phase 4
Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
Completed NCT02211118 - Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD Phase 4
Completed NCT01694745 - EUROpean Pain Audit In Neonates N/A
Completed NCT00997113 - Stress During Deep Sedation With Propofol With and Without Alfentanil Phase 4