[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594285":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":28,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":28,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":28,"enrollmentInfo":77,"targetDuration":28,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":28,"overallStatus":86,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Manitoba","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm-Penthrox","EXPERIMENTAL","Participants can begin using penthrox 10 minutes prior to procedure start, given its median onset time of 5 minutes",[13,14,15],"Drug: Methoxyflurane - Penthrox","Drug: Percocet Pill","Drug: Lorazepam (drug)",{"label":17,"type":18,"description":19,"interventionNames":20},"Control arm","PLACEBO_COMPARATOR","Patients will receive standard of care during their rezum procedure which consists of deep IV sedation.",[21],"Other: Control",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Methoxyflurane - Penthrox","Penthrox is a brand name for a drug called methoxyflurane. It is an inhaled analgesic (pain-relieving) agent used primarily for the relief of moderate to severe pain, typically in emergency medical situations or during minor medical procedures. Penthrox is administered by inhaling the vapors through a hand-held inhaler device. It acts quickly to provide pain relief and has a relatively short duration of action.",[9],null,{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Control","This intervention will be the control group only, receiving deep IV sedation.",[17],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Percocet Pill","Percocet will be given in conjunction with methoxyfluorane and lorazepam",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Lorazepam (drug)","Lorazepam will be given in conjunction with penthrox and percocet.",[9],[42],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Premal Patel, MD","CONTACT","204-221-4476","ppatel5@hsc.mb.ca",[48],{"facility":49,"status":28,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Men's Health Clinic Manitoba","Winnipeg","Manitoba","R3K 1M3","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-97.14704,49.8844,{"lat":59,"lon":58},[62,63],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":43,"role":64,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":43,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education","100594285","phase-3-trial-to-assess-the-efficacy-and-safety-during-convective-radiofrequency-water-vapor-thermal-therapy-rezum-for-benign-prostate-hyperplasia-100594285",false,"NCT07017452","Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia","Methoxyflurane + Lorazepam + Percocet (Per os) vs Deep Intravenous Sedation: A Non-inferiority Randomized Controlled Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia","Inclusion Criteria:\n\n* Able to provide an informed consent.\n* Age ≥ 18 years\n* Biological males identified with male sexual organs.\n* Scheduled for convective radiofrequency water vapor thermal therapy (REZUM) for the management of benign prostate hyperplasia.\n\nExclusion Criteria:\n\n* Concomitant use of nephrotoxic and\u002For hepatoxic agents.\n* Use of ≥ 6 ml Penthrox withing the previous 3 weeks.\n* Known allergies and\u002For adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol\n* History of genetic susceptibility to malignant hyperthermia.\n* Presence of clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment\n* Altered level of consciousness due to any cause.",true,"MALE","18 Years",{"count":78,"type":79},48,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","The primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during Rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (BPH). We propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ICH Guidelines for Good Clinical Practice as well the regulations set by the Biomedical Research Ethics Board, University of Manitoba.",[85],"Benign Prostate Hypertrophy(BPH)","NOT_YET_RECRUITING","2025-06-11",{"date":89,"type":90},"2025-06-12","ACTUAL",{"date":92,"type":79},"2025-08",{"date":94,"type":79},"2026-06",{"name":5,"class":6},1]