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

Purpose

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.

Condition

  • Vasectomy

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nitrous Oxide 		Self-Administered Nitrous Oxide
  • Drug: Nitrous Oxide
    Self-Administered Nitrous Oxide
Placebo Comparator
Placebo (Oxygen) 		Self-Administered Placebo (Oxygen)
  • Drug: Oxygen
    Self-Administered Oxygen

Recruiting Locations

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Alexandra J Berger Eberhardt, MD
617-983-4521
ajberger@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Alexandra J. Berger Eberhardt, MD

Study Contact