Actively Recruiting
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Led by Beth Israel Deaconess Medical Center · Updated on 2026-02-06
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether using nitrous oxide during vasectomy can reduce pain and anxiety, and whether patients feel more satisfied when they control their own nitrous oxide levels during the procedure. The study focuses on men scheduled for vasectomy and explores if self-adjusted nitrous oxide (SANO) might improve the care experience. It is a Phase 4 interventional trial conducted by Beth Israel Deaconess Medical Center. Participants will receive nitrous oxide at concentrations allowing minimal sedation (0-50%) throughout their vasectomy. They will wear a plastic gas mask connected to a Nitrouseal4 machine and use a handheld remote control to adjust the nitrous oxide level based on their comfort. The vasectomy procedure follows standard care with lidocaine injections given at the start. Before the procedure, staff will explain how to use the mask and remote. Before the vasectomy day, participants provide demographic and medical history information for eligibility. Anxiety and pain levels are assessed immediately before and after the procedure using scales. Follow-up surveys sent by email at two weeks and three months ask about recalled pain, anxiety, and satisfaction with the procedure. Researchers will also monitor ease of performing the vasectomy and any adverse events up to 30 days after the procedure.
CONDITIONS
Brief Title
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
You will not qualify if you...
- Perioral facial hair impeding good mask seal
- Cognitive impairment that impedes ability to complete survey questions
- Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
- Inner ear, bariatric or eye surgery within the last 2 weeks
- Current emphysematous blebs
- Severe B-12 deficiency
- Bleomycin chemotherapy within the past year
- Heart attack within the past year
- Stroke within the past 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 screening and enrollment visit
Duration - Day of vasectomy
Participants receive nitrous oxide at minimal sedation levels, which they can adjust themselves, during the vasectomy procedure.
1 in-person visit for vasectomy and nitrous oxide administration
Duration - 3 months
Participants complete electronic surveys assessing recollection of pain and anxiety, and satisfaction with the procedure at two weeks and three months after vasectomy.
2 electronic surveys sent via email
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
H
Heidi Rayala, MD, PhD
M
Michelle Shabo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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