Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Recruiting · NCT05895383 · Interventional (participants receive a specific treatment) · Lead sponsor: Beth Israel Deaconess Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.
Who can take part
Age range
21 Years to 85 Years
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
Exclusion criteria
- 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
- Has any of the following medical conditions, which contraindicate use of nitrous oxide:
- 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.
Where it is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States