NCT07245628

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Alexandra J. Berger Eberhardt, MD · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasectomy

Interventions

Type	Name	Description
DRUG	Nitrous Oxide	Self-Administered Nitrous Oxide
DRUG	Oxygen	Self-Administered Oxygen

Timeline

• Start date: 2025-10-20
• Primary completion: 2028-05-01
• Completion: 2030-05-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study