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RECRUITING
NCT07245628
EARLY_PHASE1

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

Sponsor: Alexandra J. Berger Eberhardt, MD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-10-20

Completion Date

2030-05-01

Last Updated

2025-11-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Nitrous Oxide

Self-Administered Nitrous Oxide

DRUG

Oxygen

Self-Administered Oxygen

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States