[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592462":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":42,"responsibleParty":66,"collaborators":34,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":34,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":100,"overallStatus":60,"whyStopped":34,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Dharmais National Cancer Center Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Group","PLACEBO_COMPARATOR","Participants in this arm will receive a continuous intravenous infusion of placebo (normal saline) administered in the same manner and duration as the dexmedetomidine group-starting after anesthesia induction and continuing for up to 48 hours postoperatively. This control infusion allows comparison of clinical and biochemical outcomes without the influence of dexmedetomidine.",[13],"Drug: NaCl 0,9%",{"label":15,"type":16,"description":17,"interventionNames":18},"Dexmedetomidine Group","ACTIVE_COMPARATOR","Participants assigned to this arm will receive a continuous intravenous infusion of dexmedetomidine starting after anesthesia induction and maintained throughout the surgical procedure as well as for up to 48 hours postoperatively. The infusion dose will be titrated to achieve target sedation levels while maintaining stable hemodynamics. This extended administration aims to investigate the effects of dexmedetomidine on endothelial glycocalyx preservation, inflammation modulation, thrombosis prevention, angiogenesis promotion, oxidative stress reduction, and improvement of tissue microcirculation during both intraoperative and early postoperative periods.",[19],"Drug: Dexmedetomidine",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","NaCl 0,9%","NaCl 0.9% continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively.",[9],[27],"Normal Saline",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Dexmedetomidine","Dexmedetomidine continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively, titrated to maintain target sedation and hemodynamic stability.",[15],[33],"Dexmedetomidine Hydrochloride",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Gardian Lukman Hakim, Anestesiologist","CONTACT","81218088113","+62","gardian.hakim@gmail.com",[43,59],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"NOT_YET_RECRUITING","Jakarta","DKI Jakarta","11420","Indonesia","ID",{"type":51,"coordinates":52},"Point",[53,54],106.84513,-6.21462,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":39,"phoneExt":40,"email":41},"Gardian Lukman Hakim, Anesthesiologist-Intensivist",{"facility":5,"status":60,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"RECRUITING",{"type":51,"coordinates":62},[53,54],{"lat":54,"lon":53},[65],{"name":58,"role":38,"phone":39,"phoneExt":34,"email":41},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Gardian Lukman Hakim","Anestesiologist","100592462","effect-of-dexmedetomidine-on-microsurgery-reconstruction-in-cancer-patient-100592462",false,"NCT06993740","Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient","The Effect of Dexmedetomidine Administration on the Success of Reconstructive Microsurgery in Cancer Patients: A Study of Glycocalyx Integrity, Inflammatory Response, Thrombosis, Angiogenesis, Oxidative Stress, and Tissue Microcirculation","DEXFLAP","Inclusion Criteria:\n\n1. Adult patients (aged 18-65 years) diagnosed with cancer who are scheduled to undergo microsurgical flap reconstruction.\n2. Patients within the age range of 18 to 65 years at the time of enrollment.\n3. Patients who provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with a history of uncontrolled diabetes mellitus.\n2. Patients diagnosed with chronic kidney disease.\n3. Patients with known liver failure.\n4. Patients receiving corticosteroid therapy prior to surgery.\n5. Patients with uncontrolled hypertension.\n6. Patients with a history of chemotherapy or radiotherapy prior to surgery.\n7. Patients diagnosed with preoperative sepsis.\n8. Patients requiring perioperative vasopressor support.\n9. Patients with a history of prior surgery in the same operative field.\n10. Patients who decline to participate in the study.","ALL","18 Years","65 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.",[89,90,91,92,93,94,95,96,97,98,99],"Flap Monitoring","Inflammation","Thrombosis","Oxidative Stress","Glycocalyx","Anesthesia","Surgery","Flap Ischemia","Flap Necrosis","Flap Failure Risk Factors","Microsurgery",[101,102,103,104,105,29,106,107,108,109],"SOD-1","IL-6","IL-10","VEGF","Syndecan-1","SDF","PAI-1","Flap Failure","Flap Salvage","2025-06-11",{"date":112,"type":113},"2025-06-15","ACTUAL",{"date":115,"type":113},"2025-06-10",{"date":117,"type":83},"2026-08-22",{"name":5,"class":6},2]