A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy

Alexandra J. Berger Eberhardt, MD

Status and phase

Enrolling

Early Phase 1

Conditions

Vasectomy

Treatments

Drug: Oxygen

Drug: Nitrous Oxide

Study type

Interventional

Funder types

Other

Identifiers

NCT07245628

2025P000258

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Patients with contraindications to nitrous oxide including:
Inner ear, bariatric, or eye surgery within the past 2 weeks
Current emphysematous blebs
Severe B-12 deficiency
History of bleomycin chemotherapy within the last year
Class III or higher heart failure