A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy (NCT07245628) | Clinical Trial Compass
RecruitingEarly Phase 1
A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy
United States50 participantsStarted 2025-10-20
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Timeframe: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)