RecruitingEarly Phase 1NCT07245628

A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy

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


Sponsor

Alexandra J. Berger Eberhardt, MD

Enrollment

50 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether nitrous oxide (laughing gas) that patients can self-administer during a vasectomy procedure reduces pain and anxiety compared to a placebo (no active gas). Vasectomies are typically done in-office with only local anesthesia, and this study explores if nitrous oxide offers meaningful comfort benefits. **You may be eligible if...** - You are 18 to 85 years old - You are seeking a vasectomy for family planning - You can understand and complete study questionnaires - You are willing and able to provide written consent **You may NOT be eligible if...** - You are missing one or both testicles - You have had prior scrotal surgery that would complicate a vasectomy - You have conditions where nitrous oxide is unsafe (e.g., certain vitamin deficiencies, lung problems, recent ear surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNitrous Oxide

Self-Administered Nitrous Oxide

DRUGOxygen

Self-Administered Oxygen


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT07245628


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