Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age21-85
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Scheduled for vasectomy
Aged 21 to 85 years
Suitable for receipt of inhaled nitrous oxide/oxygen
Access to an email and computer
Disqualifiers
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
Inner ear, bariatric or eye surgery within the last 2 weeks,
Trial design
Design model
Single group
Treatments tested in this trial
Nitrous oxide
DrugNitrous 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Self-adjusted nitrous oxide (SANO)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Measured immediately after completion of vasectomySecondary outcomes
1
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).
Time frame
Measured immediately prior to vasectomy2
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).
Time frame
Measured immediately prior to vasectomy3
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).
Time frame
Measured immediately after completion of vasectomy4
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).
Time frame
Measured two weeks and three months after vasectomySponsors and contacts
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Source ClinicalTrials.gov