A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting. This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy. The main questions it aims to answer are: * Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy. * To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure. Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age 18 - 85 at the time of screening

• Desiring vasectomy for family planning purposes

• Able to understand and complete patient questionnaires

• Willing and able to provide written consent to participate in the study

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 50
Treatments
Experimental: Nitrous Oxide
Self-Administered Nitrous Oxide
Placebo_comparator: Placebo (Oxygen)
Self-Administered Placebo (Oxygen)
Related Therapeutic Areas
Sponsors
Leads: Alexandra J. Berger Eberhardt, MD

This content was sourced from clinicaltrials.gov