Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

2023P-000328

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.

2023-05-24

2023-09-30

2023-11-30

Recruiting

Early phase I

35

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive nitrous oxide at levels of mild sedation during vasectomy. Participants will hold a remote control to adjust the level of gas administered according to their comfort level.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}

2023-06-15