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

NCT07245628 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

DRUG

Nitrous Oxide

Self-Administered Nitrous Oxide

DRUG

Oxygen

Self-Administered Oxygen

Sponsors & Collaborators

  • Alexandra J. Berger Eberhardt, MD

    lead OTHER

Principal Investigators

  • Alexandra J Berger Eberheardt, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2028-05-01
Completion
2030-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245628 on ClinicalTrials.gov