MedTrace Logo

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

NCT05895383 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Procedural Pain
  • Pain Catastrophizing
  • Procedural Anxiety

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Heidi Rayala, MD, PhD · Beth Israel Deaconess Medical Center

  • Marissa Kent, MD · Beth Israel Deaconess Medical Center

  • Peter Steinberg, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-24
Primary Completion
2027-01-30
Completion
2027-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05895383 on ClinicalTrials.gov