Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy (SANO-VAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Procedural Pain; Pain Catastrophizing; Procedural Anxiety
• Intervention / Treatment: Drug: Nitrous oxide

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heidi Rayala, MD, PhD; Phone Number: 617-667-3739; Email: hrayala@bidmc.harvard.edu
• Study Contact Backup: Name: Michelle Shabo, MD; Email: mshabo@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Peter Healy; Email: phealy1@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Scheduled for vasectomy
2. Aged 21 to 85 years
3. Suitable for receipt of inhaled nitrous oxide/oxygen
4. Access to an email and computer

Exclusion Criteria:

1. Perioral facial hair impeding good mask seal
2. Cognitive impairment that impedes ability to complete survey questions
3. Intent to use benzodiazepines or opioids "as needed" for purposes of vasectomy

4. Has any of the following medical conditions, which contraindicate use of nitrous oxide:

   1. Inner ear, bariatric or eye surgery within the last 2 weeks,
   2. Current emphysematous blebs,
   3. Severe B-12 deficiency,
   4. Bleomycin chemotherapy within the past year,
   5. Heart attack within the past year,
   6. Stroke within the past year,
   7. Class III or higher heart failure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-adjusted nitrous oxide (SANO); All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.	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.; Other Names: Self-adjusted nitrous oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator ease of performing vasectomy	Operating urologist will be asked to fill out a three-item "operator survey" that asks if "Patient tolerated lidocaine injection," "Patient maintained positioning," and "Patient tolerated vasectomy," "Worse than expected (-1)", "As expected (0)" or "Better than expected (+1)." The composite score will be used as a measure of operator ease.	Measured immediately after urologist finishes vasectomy
Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)	Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).	Measured immediately prior to vasectomy
Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)	Level of anxiety anticipated during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).	Measured immediately prior to vasectomy
Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)	Level of anxiety experienced during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).	Measured immediately after completion of vasectomy
Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)	Level of pain recalled during vasectomy as measured by the Visual Analog Scale for Pain (VAS-P; range: 0 no pain - 10 worst pain).	Measured two weeks and three months after vasectomy
Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)	Level of anxiety recalled during vasectomy as measured by the Visual Analog Scale for Anxiety (VAS-A; range: 0 no anxiety - 10 worst anxiety).	Measured two weeks and three months after vasectomy
Satisfaction assessed by Likert scale	Satisfaction of concentration of SANO during vasectomy will be measured by the maximum concentration of SANO reached during the procedure compared to participants' response to: "How do you feel about the level of SANO you received during the vasectomy?" (less than I would like, about right, more than I would like) and "How helpful do you think SANO was in relieving your pain and anxiety?" (very helpful, unhelpful, undecided, helpful very helpful).	Measured during and two weeks after vasectomy
Emergent adverse events as assessed by frequency of incidents	Emergent adverse events possibly related to SANO will be recorded by frequency on the day-of the vasectomy and by monitoring participants' online medical record up to 30 days after the vasectomy. Termination of SANO during the vasectomy due to discomfort, nausea, or vomiting will also be considered as adverse events related to SANO.	Measured during and up to 30 days after day of vasectomy

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Heidi Rayala, MD, PhD, Beth Israel Deaconess Medical Center; Study Chair: Marissa Kent, MD, Beth Israel Deaconess Medical Center; Study Chair: Peter Steinberg, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ambulatory; nitrous oxide; vasectomy; experience of care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Gases; Nitrogen Oxides; Nitrous Oxide
• Other Study ID Numbers: 2023P-000328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes