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

Beth Israel Lahey Health

Status and phase: Enrolling; Phase 4

Conditions: Procedural Anxiety; Pain Catastrophizing; Procedural Pain

Treatments: Drug: Nitrous oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT05895383

2023P-000328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: Male

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Self-adjusted nitrous oxide (SANO)

Experimental group

Description:

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

Treatment:

Drug: Nitrous oxide