Actively Recruiting
A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy
Led by Alexandra J. Berger Eberhardt, MD · Updated on 2025-11-24
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years 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
You will not qualify if you...
- Unilateral absence of the vas deferens
- Anatomy not suitable for office vasectomy procedure as determined by study surgeons
- Declining office vasectomy and requesting monitored anesthesia care
- Taking benzodiazepine or narcotic medication daily or within 24 hours before the procedure
- Contraindications to nitrous oxide including:
- Inner ear, bariatric, or eye surgery within the past 2 weeks
- Current emphysematous blebs
- Severe vitamin B-12 deficiency
- History of bleomycin chemotherapy within the last year
- Class III or higher heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo office vasectomy while self-administering either nitrous oxide or placebo (oxygen) during the procedure to support pain and anxiety management.
1 procedure visit (in-person)
Duration - 30 days after vasectomy
Participants are observed for complications and adverse events following the vasectomy procedure.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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