Recruiting
Early Phase 1

SANO

Sponsor:

Alexandra J. Berger Eberhardt, MD

Code:

NCT07245628

Conditions

Vasectomy

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nitrous Oxide

Oxygen

Study Details

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 ID

NCT07245628

Start date

Oct 20, 2025

Status verified date

Nov, 2025

Completion date

May 1, 2030

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Nitrous Oxide

Self-Administered Nitrous Oxide

placebo comparator: Placebo (Oxygen)

Self-Administered Placebo (Oxygen)

Interventions

Nitrous Oxide

Self-Administered Nitrous Oxide

Oxygen

Self-Administered Oxygen

Primary outcome measure

  • Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [ Time Frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized) ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Alexandra J Berger Eberhardt, MD

617-983-4521ajberger@bwh.harvard.edu

More Information

Sponsor

Alexandra J. Berger Eberhardt, MD

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Vasectomy
  • Nitrous Oxide
  • Men's Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexandra J. Berger Eberhardt, MD on 2025-11-24.