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

NCT07245628 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2025P000258
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Vasectomy; Nitrous Oxide; Men's Health

Outcome Measures

Primary Outcomes (1)

• 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

  Measuring the mean difference in Visual Analog Scale for Anxiety (VAS-A) during the vasectomy procedure and the Situational Pain Catastrophizing Scale (S-PCS) immediately after the vasectomy procedure, comparing those receiving and not receiving self-administered low dose nitrous oxide. Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety) Intra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety) Post-Procedure (10 Minutes After Procedure Completion, to Allow for Nitrous Oxide to be Metabolized) 1. Situational Pain Catastrophizing Scale (S-PCS) (Zero is equivalent to not at all and 4 indicates all the time) 2. Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)

  Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)

Secondary Outcomes (6)

• Mean Difference in Visual Analog Scale for Pain (VAS-P) Intra-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

  Intra-Procedure (Immediately After Injection of Local Anesthesia) - Intra-Procedure (In Between Left and Right Sides of Procedure)

• Mean Difference in VAS-P and STAI Pre- and Post-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

  Pre-Procedure (Day of Procedure, Immediately Prior) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)

• Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

  Study Enrollment - 30 Days After Vasectomy

• Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

  Post-Procedure, Day of Vasectomy

• Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide

  Post-Procedure, Day of Vasectomy

Study Arms (2)

Nitrous Oxide

EXPERIMENTAL

Self-Administered Nitrous Oxide

Drug: Nitrous Oxide

Placebo (Oxygen)

PLACEBO COMPARATOR

Self-Administered Placebo (Oxygen)

Drug: Oxygen

Interventions

Nitrous Oxide DRUG

Self-Administered Nitrous Oxide

Nitrous Oxide

Oxygen DRUG

Self-Administered Oxygen

Placebo (Oxygen)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandra J. Berger Eberhardt, MD: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Nitrous Oxide; Oxygen

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Study Officials

• Alexandra J Berger Eberheardt, MD

  Brigham and Women's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Surgeon, Department of Urology, Brigham and Women's Hospital; Assistant Professor, Harvard Medical School

Study Record Dates

• First Submitted: November 10, 2025
• First Posted: November 24, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)