Self-adjusted nitrous oxide versus placebo during in-office vasectomy
A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy
EARLY_PHASE1 · Brigham and Women's Hospital · NCT07245628
This will see if self-administered low-dose nitrous oxide (20–45%) helps reduce anxiety, catastrophizing, and pain for adults having an in-office vasectomy.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07245628 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional trial compares self-administered low-dose nitrous oxide (20–45%) with placebo oxygen during office vasectomy procedures. Participants self-administer gas during the procedure and complete questionnaires before, during, and after the operation about anxiety, catastrophizing, and pain. Secondary outcomes include procedure duration, adverse event rates, and urologists' ratings of ease and patient tolerance. The single-site study is conducted at Brigham and Women's Hospital and enrolls adults aged 18–85 who desire vasectomy and have no contraindications to nitrous oxide.
Who should consider this trial
Good fit: Adult men aged 18–85 seeking an office vasectomy who can consent, complete questionnaires, and do not have contraindications to nitrous oxide or recent daily benzodiazepine/opioid use.
Not a fit: Men with surgical anatomy unsuitable for office vasectomy, those requiring monitored anesthesia care, or those with contraindications to nitrous oxide (recent ear/bariatric/eye surgery, emphysematous blebs, severe B12 deficiency, recent bleomycin, or class III+ heart failure) are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could make vasectomies less anxiety-provoking and painful, improving patient comfort and procedure tolerance.
How similar studies have performed: Nitrous oxide has a long history of safe anxiety and pain relief in dental and obstetric settings, but its use specifically for office vasectomy is relatively novel and not well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vasectomy, Nitrous Oxide, Men's Health