Clinical trial NCT05895383: Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Official title: Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Procedural Pain
Pain Catastrophizing
Procedural Anxiety
Keywords: vasectomy
nitrous oxide
experience of care
ambulatory
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 35
Sex: MALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
timeFrame: Measured immediately after completion of vasectomy
Secondary outcomes:
measure: Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)
timeFrame: Measured immediately prior to vasectomy
measure: Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
timeFrame: Measured immediately prior to vasectomy
measure: Procedural anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
timeFrame: Measured immediately after completion of vasectomy
measure: Recalled pain assessed by the Visual Analog Scale for Pain (VAS-P)
timeFrame: Measured two weeks and three months after vasectomy
measure: Recalled anxiety assessed by the Visual Analog Scale for Pain (VAS-P)
timeFrame: Measured two weeks and three months after vasectomy
measure: Satisfaction assessed by Likert scale
timeFrame: Measured during and two weeks after vasectomy
measure: Operator ease of performing vasectomy
timeFrame: Measured immediately after urologist finishes vasectomy
measure: Emergent adverse events as assessed by frequency of incidents
timeFrame: Measured during and up to 30 days after day of vasectomy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Heidi Rayala, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Marissa Kent, MD
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess Medical Center
name: Peter Steinberg, MD
role: STUDY_CHAIR
References: