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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Alexandra J. Berger Eberhardt, MD
Study ID
NCT07245628
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Vasectomy

Eligibility Criteria

Sex
MALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Nitrous Oxide — DRUG
    Self-Administered Nitrous Oxide
  • Oxygen — DRUG
    Self-Administered Oxygen

Study Details

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.

Key Dates

Start date
Oct 20, 2025
Status verified
Nov 2025
Primary completion
May 1, 2028
Completion
May 1, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nitrous Oxide
    Self-Administered Nitrous Oxide
  • Placebo Comparator: Placebo (Oxygen)
    Self-Administered Placebo (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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Alexandra J Berger Eberhardt, MD
[email protected]
617-983-4521

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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