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Early Phase 1
Age: 18Years - 85Years
MALE
ID07245628

Study of Self-Adjusted Nitrous Oxide Versus Placebo During Office Vasectomy to Reduce Anxiety and Pain

Led by Alexandra J. Berger Eberhardt, MD · Updated on 2025-11-24

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether self-administered low dose nitrous oxide is safe and effective when used during office-based vasectomy procedures. The trial aims to compare nitrous oxide with a placebo oxygen to see if it reduces anxiety and catastrophizing during the procedure. It also looks at its effects on pain, procedure duration, adverse events, and urologists views on the ease and patient tolerance of the procedure. Participants will be randomly assigned to receive either self-administered nitrous oxide or a placebo oxygen during their vasectomy. The nitrous oxide dose ranges from 20% to 45%, and it is self-adjusted by the participant. The trial is single-blind, meaning participants do not know which treatment they receive. Surveys will be completed before, during, and after the procedure to assess anxiety, pain, and other factors. During the study, participants will complete multiple surveys to measure anxiety using VAS-A and catastrophizing with S-PCS immediately after the procedure. Pain levels will also be assessed during and after the procedure using visual analog scales. Researchers will monitor adverse events for 30 days post-procedure and evaluate urologists assessments of procedure ease and patient tolerance. The study includes participants aged 18 to 85 and involves careful follow-up to gather all relevant data.

CONDITIONS

Brief Title

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

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