NCT05895383

Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Male
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.

Detailed description

Patients scheduled for vasectomy at Beth Israel Deaconess Medical Center will be contacted and offered enrollment in the study. Vasectomy will occur according to standard-of-care and all participants will receive the typical lidocaine injections at the beginning of the procedure. Before the start of the vasectomy, a study staff member will help participants put on a plastic gas mask and demonstrate how to turn the gas up or down using the remote control. Nitrous oxide and oxygen will be given through a plastic mask. A remote control given to participants will allow them to adjust the nitrous oxide based on their comfort. The Nitrouseal® machine used in this study limits nitrous oxide to concentrations to "minimal sedation" (0-50%), which are levels where a person remains awake and is able to talk and breath normally. Before the day of a participant's vasectomy, they will be asked questions related to demographics and medical history to determine study eligibility. Immediately before and after vasectomy, participants will be asked to describe their anxiety and pain levels. At two-weeks and three-months after vasectomy, a brief electronic survey will be sent to participants' email asking about recollection of pain and anxiety and satisfaction with the procedure.

Conditions

• Procedural Pain
• Pain Catastrophizing
• Procedural Anxiety

Interventions

Type	Name	Description
DRUG	Nitrous oxide	Nitrous oxide administered at concentrations of minimal sedation (0-50%). Participants will be able to adjust the level of gas throughout the vasectomy using a handheld remote control.

Timeline

• Start date: 2023-05-24
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2023-06-08
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study