[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508052":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":35,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":35,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":42,"whyStopped":35,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Self-adjusted nitrous oxide (SANO)","EXPERIMENTAL","All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.",[13],"Drug: Nitrous oxide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],[21],"Self-adjusted nitrous oxide",[23,26,29],{"name":24,"affiliation":5,"role":25},"Heidi Rayala, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":28},"Marissa Kent, MD","STUDY_CHAIR",{"name":30,"affiliation":5,"role":28},"Peter Steinberg, MD",[32,37],{"name":24,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","617-667-3739",null,"hrayala@bidmc.harvard.edu",{"name":38,"role":33,"phone":35,"phoneExt":35,"email":39},"Michelle Shabo, MD","mshabo@bidmc.harvard.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":35,"phoneExt":35,"email":57},"Peter Healy","phealy1@bidmc.harvard.edu",{"type":25,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Heidi Rayala","Assistant Professor of Surgery","100508052","phase-4-self-adjusted-nitrous-oxide-a-feasibility-study-in-the-setting-of-vasectomy-100508052",false,"NCT05895383","Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy","SANO-VAS","Inclusion Criteria:\n\n1. Scheduled for vasectomy\n2. Aged 21 to 85 years\n3. Suitable for receipt of inhaled nitrous oxide\u002Foxygen\n4. Access to an email and computer\n\nExclusion Criteria:\n\n1. Perioral facial hair impeding good mask seal\n2. Cognitive impairment that impedes ability to complete survey questions\n3. Intent to use benzodiazepines or opioids \"as needed\" for purposes of vasectomy\n4. Has any of the following medical conditions, which contraindicate use of nitrous oxide:\n\n   1. Inner ear, bariatric or eye surgery within the last 2 weeks,\n   2. Current emphysematous blebs,\n   3. Severe B-12 deficiency,\n   4. Bleomycin chemotherapy within the past year,\n   5. Heart attack within the past year,\n   6. Stroke within the past year,\n   7. Class III or higher heart failure.",true,"MALE","21 Years","85 Years",{"count":73,"type":74},35,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","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.",[80,81,82],"Procedural Pain","Pain Catastrophizing","Procedural Anxiety",[84,85,86,87],"vasectomy","nitrous oxide","experience of care","ambulatory","2026-02-04",{"date":90,"type":91},"2026-02-06","ACTUAL",{"date":93,"type":91},"2023-05-24",{"date":95,"type":74},"2027-01-30",{"name":5,"class":6},1]