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

NCT05895383 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2023P-000328
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vasectomy; nitrous oxide; experience of care; ambulatory

Outcome Measures

Primary Outcomes (1)

• Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)

  Level of pain experienced during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).

  Measured immediately after completion of vasectomy

Secondary Outcomes (8)

• Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)

  Measured immediately prior to vasectomy

• Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)

  Measured immediately prior to vasectomy

• Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)

  Measured immediately after completion of vasectomy

• Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)

  Measured two weeks and three months after vasectomy

• Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)

  Measured two weeks and three months after vasectomy

Study Arms (1)

Self-adjusted nitrous oxide (SANO)

EXPERIMENTAL

All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.

Drug: Nitrous oxide

Interventions

Nitrous oxide DRUG

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.

Also known as: Self-adjusted nitrous oxide

Self-adjusted nitrous oxide (SANO)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for vasectomy
• Aged 21 to 85 years
• Suitable for receipt of inhaled nitrous oxide/oxygen
• Access to an email and computer

You may not qualify if:

• Perioral facial hair impeding good mask seal
• Cognitive impairment that impedes ability to complete survey questions
• Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy
• Has any of the following medical conditions, which contraindicate use of nitrous oxide:
• Inner ear, bariatric or eye surgery within the last 2 weeks,
• Current emphysematous blebs,
• Severe B-12 deficiency,
• Bleomycin chemotherapy within the past year,
• Heart attack within the past year,
• Stroke within the past year,
• Class III or higher heart failure.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• Heidi Rayala, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Marissa Kent, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

• Peter Steinberg, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Central Study Contacts

Heidi Rayala, MD, PhD

CONTACT

617-667-3739; hrayala@bidmc.harvard.edu

Michelle Shabo, MD

CONTACT

mshabo@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: All participants will receive nitrous oxide at levels of mild sedation during vasectomy. Participants will hold a remote control to adjust the level of gas administered according to their comfort level.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: May 24, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)