A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy
ConditionVasectomy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-85
SponsorAlexandra J. Berger Eberhardt, MD
About this trial
The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting.
This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy.
The main questions it aims to answer are:
* Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy. * To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure.
Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.
Eligibility criteria
Qualifiers
Age 18 - 85 at the time of screening
Desiring vasectomy for family planning purposes
Able to understand and complete patient questionnaires
Willing and able to provide written consent to participate in the study
Disqualifiers
Patients with unilateral absence of the vas deferens
Patients who are deemed by study surgeons to have anatomy no amendable for office procedure
Patients who decline office vasectomy and request monitored anesthesia care
Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure
Trial design
Treatments tested in this trial
- Nitrous Oxide
- Oxygen
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Alexandra J. Berger Eberhardt, MD
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Source ClinicalTrials.gov