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

NCT ID: NCT07245628

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2030-05-01

Brief Summary

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.

Conditions

Vasectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Nitrous Oxide

Self-Administered Nitrous Oxide

Group Type: EXPERIMENTAL

Nitrous Oxide

Intervention Type: DRUG

Self-Administered Nitrous Oxide

Placebo (Oxygen)

Self-Administered Placebo (Oxygen)

Group Type: PLACEBO_COMPARATOR

Oxygen

Intervention Type: DRUG

Self-Administered Oxygen

Interventions

Nitrous Oxide

Self-Administered Nitrous Oxide

Intervention Type: DRUG

Oxygen

Self-Administered Oxygen

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandra J. Berger Eberhardt, MD

OTHER

Sponsor Role: lead

Responsible Party

Alexandra J. Berger Eberhardt, MD

Associate Surgeon, Department of Urology, Brigham and Women's Hospital; Assistant Professor, Harvard Medical School

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexandra J Berger Eberheardt, MD

Role: STUDY_CHAIR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Alexandra J Berger Eberhardt, MD

Role: primary

ajberger@bwh.harvard.edu

617-983-4521

Other Identifiers

2025P000258

Identifier Type: -

Identifier Source: org_study_id