Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nitrous oxide.
- Who it may be relevant to
- Registry conditions: Procedural Pain, Pain Catastrophizing, Procedural Anxiety. Basic parameters: 21 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
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.
Primary outcome measures
- Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P) [Time frame: Measured immediately after completion of vasectomy]
Secondary outcome measures (8)
- Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P) [Time frame: Measured immediately prior to vasectomy]
- Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A) [Time frame: Measured immediately prior to vasectomy]
- Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A) [Time frame: Measured immediately after completion of vasectomy]
- Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P) [Time frame: Measured two weeks and three months after vasectomy]
- Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P) [Time frame: Measured two weeks and three months after vasectomy]
- Satisfaction assessed by Likert scale [Time frame: Measured during and two weeks after vasectomy]
- Operator ease of performing vasectomy [Time frame: Measured immediately after urologist finishes vasectomy]
- Emergent adverse events as assessed by frequency of incidents [Time frame: Measured during and up to 30 days after day of vasectomy]
Eligibility criteria
Inclusion criteria
- Scheduled for vasectomy
- Aged 21 to 85 years
- Suitable for receipt of inhaled nitrous oxide/oxygen
- Access to an email and computer
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT05895383 · 2023P-000328