Recruiting

SANO

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05895383

Conditions

Procedural Pain

Pain Catastrophizing

Procedural Anxiety

Eligibility Criteria

Sex: Male

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Nitrous oxide

Study Details

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

Study ID

NCT05895383

Start date

May 24, 2023

Status verified date

Feb, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Self-adjusted nitrous oxide (SANO)

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

Interventions

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.

Primary outcome measure

  • Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P) [ Time Frame: Measured immediately after completion of vasectomy ]

Central Contacts and Locations

Central contacts

Heidi Rayala, MD, PhD

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

Michelle Shabo, MD

mshabo@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Peter Healy

phealy1@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • vasectomy
  • nitrous oxide
  • experience of care
  • ambulatory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-02-06.