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Recruiting NCT07245628

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

Early Phase I Interventional Vasectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitrous Oxide, Oxygen.
Who it may be relevant to
Registry conditions: Vasectomy. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy

Overview

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.

Interventions

  • Drug Nitrous Oxide
    Self-Administered Nitrous Oxide
  • Drug Oxygen
    Self-Administered Oxygen

Primary outcome measures

  • 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)]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: Study Enrollment - 30 Days After Vasectomy]
  • Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Time frame: Post-Procedure, Day of Vasectomy]
  • Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide [Time frame: Post-Procedure, Day of Vasectomy]
  • Mean Difference in Duration of 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT07245628 · 2025P000258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗