RecruitingRecruiting
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
NCT05895383 · Beth Israel Deaconess Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally.
Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.
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.
Study design
Enrollment target: 35 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-05-24
Estimated completion: 2027-01-30
Last updated: 2026-02-06
Interventions
Drug: Nitrous oxide
Primary outcomes
- • Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P) (Measured immediately after completion of vasectomy)
Sponsor
Beth Israel Deaconess Medical Center · other
Contacts & investigators
ContactHeidi Rayala, MD, PhD · contact · hrayala@bidmc.harvard.edu · 617-667-3739
ContactMichelle Shabo, MD · contact · mshabo@bidmc.harvard.edu
InvestigatorHeidi Rayala, MD, PhD · principal_investigator, Beth Israel Deaconess Medical Center
InvestigatorMarissa Kent, MD · study_chair, Beth Israel Deaconess Medical Center
InvestigatorPeter Steinberg, MD · study_chair, Beth Israel Deaconess Medical Center
All locations (1)
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States