NCT05895383 Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
| NCT ID | NCT05895383 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Procedural Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 35 participants in total. It began in 2023-05-24 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Heidi Rayala, MD, PhD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT05895383 clinical trial?
This trial is open to male participants only, aged 21 Years or older, up to 85 Years, studying Procedural Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05895383 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05895383 currently recruiting?
Yes, NCT05895383 is actively recruiting participants. Contact the research team at hrayala@bidmc.harvard.edu for enrollment information.
Where is the NCT05895383 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05895383 clinical trial?
NCT05895383 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Heidi Rayala, MD, PhD at Beth Israel Deaconess Medical Center. The trial plans to enroll 35 participants.