NCT07245628EARLY_PHASE1Recruiting

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

Alexandra J. Berger Eberhardt, MD

Start Date

10/20/2025

Completion Date

5/1/2030

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 Criteria

Age Range: 18 years to 85 years

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with unilateral absence of the vas deferens * Patients who are deemed by study surgeons to have anatomy no amendable for office procedure * Patients who decline office vasectomy and request monitored anesthesia care * Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure * Patients with contraindications to nitrous oxide including: * Inner ear, bariatric, or eye surgery within the past 2 weeks * Current emphysematous blebs * Severe B-12 deficiency * History of bleomycin chemotherapy within the last year * Class III or higher heart failure

Interventions

DRUG

Nitrous Oxide

DRUG

Oxygen

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Conditions

Vasectomy

Locations

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States