[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565327":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":43,"collaborators":31,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":31,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":31,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":68,"whyStopped":31,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":31},{"fullName":5,"class":6},"Kaohsiung Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"arm 1","EXPERIMENTAL","During uterine fibroid ablation, the arm1 participant received Remifentanil \\[ ALVOGEN® (2 mg\u002Fvial)\\] 1.0 ng\u002FmL via syringe infusion pump \\[Perfusor® Space \\| B. Braun\\] as a pain treatment.",[13],"Drug: arm 1",{"label":15,"type":16,"description":17,"interventionNames":18},"arm 2","ACTIVE_COMPARATOR","During uterine fibroid ablation, the arm2 participant received Remifentanil \\[ ALVOGEN® (2 mg\u002Fvial)\\] 2.0 ng\u002FmL via syringe infusion pump \\[Perfusor® Space \\| B. Braun\\] as a pain treatment.",[19],"Drug: arm 2",[21,28],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","This study tries to find the best drug concentration of Remifentanil, ALVOGEN® (2 mg\u002Fvial) in Uterine Fibroid Ablation. We have two arms. Arm 1 with Remifentanil, ALVOGEN® (2 mg\u002Fvial) 1.0 ng\u002FmL, and arm 2 with Remifentanil, ALVOGEN® (2 mg\u002Fvial) 2.0 ng\u002FmL, both given via a syringe infusion pump, Perfusor® Space \\| B. Braun.",[15],[26,27],"ALVOGEN","Remifentanil ALVOGEN®",{"type":22,"name":9,"description":23,"armGroupLabels":29,"otherNames":30},[9],[27],null,[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Ying Tzu Li, Master's degree","CONTACT","886-7-3121101","7035","irb-app@kmuh.org.tw",{"name":40,"role":35,"phone":36,"phoneExt":41,"email":42},"Kuang I Cheng, Doctor of Philosophy Ph.D.","7184","trustwithtrust@gmail.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Tzu Ying Li","Attending Physician","100565327","phase-4-investigating-the-optimal-remifentanil-and-dexmedetomidine-concentration-for-uterine-fibroid-ablation-100565327",false,"NCT06640738","Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation","Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study","Inclusion Criteria:\n\n* Aged between 20 and 65 years old\n* American Society of Anesthesiology classification I\\~III\n* Female patients diagnosed with uterine fibroids by obstetricians and gynecologists\n\nExclusion Criteria:\n\n1. Patients with heart disease (such as arrhythmia or severe ventricular dysfunction)\n2. Patients with chronic kidney disease in stage III or above or dialysis patients\n3. Long-term alcohol addiction or drug abuse\n4. Patients with abnormal liver index or chronic hepatitis\n5. Those who are allergic Remifentanil\n6. Those who refuse to participate in the experiment","FEMALE","20 Years","65 Years",{"count":58,"type":59},60,"ESTIMATED","INTERVENTIONAL",[62],"PHASE4","This clinical trial aims to find a better drug concentration of Remifentanil in Uterine Fibroid Ablation. The main question it seeks to answer is:\n\n\\[primary hypothesis 1\\] Remifentanil concentration of 2.0 ng\u002FmL provides better pain control in Uterine Fibroid Ablation.\n\nThere is a comparison group in this study: Researchers will compare Remifentanil concentration of 1.0 ng\u002FmL to see if provides similar pain control with fewer side effects.\n\nParticipants will be separated into two groups, one group with a Remifentanil concentration of 2.0 ng\u002FmL and the other 1.0 ng\u002FmL. During uterine fibroid ablation, the patient\\'s pain index will be recorded (using a Visual Analogue Scale (VAS) of 0\\~10 points). We will also record vital signs during the procedure.",[65],"Uterine Fibroids (UF)",[65,67],"Remifentanil","NOT_YET_RECRUITING","2024-10-11",{"date":71,"type":72},"2024-10-15","ACTUAL",{"date":74,"type":59},"2024-10-01",{"date":76,"type":59},"2026-10-31",{"name":5,"class":6}]