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Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
RECRUITINGPhase 4Sponsored by Beth Israel Deaconess Medical Center
Actively Recruiting
PhasePhase 4
SponsorBeth Israel Deaconess Medical Center
Started2023-05-24
Est. completion2027-01-30
Eligibility
Age21 Years – 85 Years
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05895383
Summary
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.
Eligibility
Age: 21 Years – 85 YearsSex: MALEHealthy volunteers accepted
Inclusion Criteria: 1. Scheduled for vasectomy 2. Aged 21 to 85 years 3. Suitable for receipt of inhaled nitrous oxide/oxygen 4. Access to an email and computer Exclusion Criteria: 1. Perioral facial hair impeding good mask seal 2. Cognitive impairment that impedes ability to complete survey questions 3. Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy 4. Has any of the following medical conditions, which contraindicate use of nitrous oxide: 1. Inner ear, bariatric or eye surgery within the last 2 weeks, 2. Current emphysematous blebs, 3. Severe B-12 deficiency, 4. Bleomycin chemotherapy within the past year, 5. Heart attack within the past year, 6. Stroke within the past year, 7. Class III or higher heart failure.
Conditions4
AnxietyPain CatastrophizingProcedural AnxietyProcedural Pain
Locations1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Peter Healyphealy1@bidmc.harvard.edu
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Actively Recruiting
PhasePhase 4
SponsorBeth Israel Deaconess Medical Center
Started2023-05-24
Est. completion2027-01-30
Eligibility
Age21 Years – 85 Years
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05895383