[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575242":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":12,"centralContacts":38,"locations":48,"responsibleParty":64,"collaborators":12,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":12,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":12,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":12,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"King Abdulaziz Medical City","OTHER_GOV",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Controlled","NO_INTERVENTION","Group A: Control group. Receiving plain isobaric \"Bupivacaine 0.5%\", \"Bucaine®,\" (2.4 ml) + 0.15 ml of normal saline (placebo), total volume = 2.4 ml.\n\nThrough IV, 15 ml of normal saline ( placebo) will be received over 30 mins.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Dexmedetomidine HCL IT","EXPERIMENTAL","Group B: RECEIVING IT \"Dexmedetomidine HCL,\" \"Demexa®,\" Through IT, receiving plain isobaric \"Bupivacaine 0.5%\", \"Bucaine®,\" (2.4 ml) +3mcg of \"Dexmedetomidine HCL, (0.15 ml), total volume = 2.4 ml.\n\nThrough IV, 15 ml of normal saline ( placebo) will be received over 30 mins.",[18],"Drug: Interventional group#1",{"label":20,"type":15,"description":21,"interventionNames":22},"Dexmedetomidine HCL IV","Group C: RECEIVING IV \"Dexmedetomidine HCL,\" \"Demexa®,\"\n\nThrough IT, receiving plain isobaric \"Bupivacaine 0.5%\", \"Bucaine®,\" (2.4 ml) + Placebo of normal saline (0.15 ml), total volume = 2.4 ml.\n\nThrough IV, 0.5 mcg\u002Fkg of \"Dexmedetomidine HCL\" is prepared in a concentration of 2 mcg\u002Fml ( maximum of 15 ml, 30 mcg) over 30 mins.",[23],"Drug: Interventional group#2",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Interventional group#1","The intrathecal mixture of spinal anesthesia: 12 mg of isobaric \"Bupivacaine 0.5%\", \"Bucaine®,\" (2.4 ml) + 20 mcg of \"Fentanyl,\" \"Martindale pharma Fentanyl®,\" 50mcg\u002Fml (0.4ml) + 3 mcg of \"Dexmedetomidine HCL,\" \"Demexa®,\" 4mcg\u002Fml (0.75 ml) total volume = 3.55 ml.\n\nThe Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision. The Bromage score is a clinical scale used to determine motor block during regional anesthesia by evaluating lower limb movement: Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block). Dermatomal coverage will be assessed simultaneously till it reaches the L1-L2 level. Also, The Ramsay Sedation Scale (RSS) will be used to evaluate the sedation depth, if any.",[14],[31],"Intrathecal \"Dexmedetomidine HCL,\" \"Demexa®,\"",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Interventional group#2","The intrathecal mixture of spinal anesthesia: 12 mg of isobaric \"Bupivacaine 0.5%\", \"Bucaine®,\" (2.4 ml) + 20 mcg of \"Fentanyl,\" \"Martindale pharma Fentanyl®,\" 50mcg\u002Fml (0.4ml) total volume = 2.8 ml.\n\nThe intravascular mixture consists of 0.5 mcg\u002Fkg of \"Dexmedetomidine HCL,\" \"Demexa®,\" and a maximum of 30 mcg diluted to 4 mcg\u002Fml. According to body weight, the total volume is 7.5 ml or less and given using a syringe pump over 30 minutes. The anesthesiologist will start the infusion once the patient is positioned supine post-spinal anesthesia and has stable hemodynamics. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision reaches grade 3: No movement in hips, knees, or ankles (complete block). The anesthesiologist will assess dermatomal coverage until it reaches the L1-L2 and calculate the Ramsay Sedation Scale (RSS) of the depth of sedation aiming for level 2: Patient is cooperative, oriented, and calm",[20],[37],"Intravascular \"Dexmedetomidine HCL,\" \"Demexa®,\"",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":12,"email":43},"Hebah Musalem, Anesthesia Asistant consultant","CONTACT","00966533112656","hebamusallam91@gmail.com",{"name":45,"role":41,"phone":46,"phoneExt":12,"email":47},"Mohammad Al Harbi, Anesthesia Consultant,","00966508818000","HarbiMK@mngha.med.sa",[49],{"facility":5,"status":12,"city":50,"state":12,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Riyadh","11551","Saudi Arabia","SA",{"type":55,"coordinates":56},"Point",[57,58],46.72185,24.68773,{"lat":58,"lon":57},[61],{"name":62,"role":41,"phone":63,"phoneExt":12,"email":43},"Heba Musalem","0533112656",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Hebah Musalem","Anesthesia Assistant consultant","100575242","phase-4-the-prolonging-effect-of-dexmedetomidine-on-spinal-anesthesia-through-different-routes-if-administrations-100575242",false,"NCT06769737","The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations","The Prolonged Effects of Spinal Dexmedetomidine Versus Intravenous Dexmedetomidine on Spinal Anesthesia With Isobaric Bupivacaine: A Comparative Study","Inclusion Criteria:\n\n* Male and female patients in adult age group more than 18 years old\n* ASA classification I, II, and III.\n* Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).\n* No history of Obstructive sleep apnea\n\nExclusion Criteria:\n\n* Patient below 18 years old of both genders.\n* ASA classification of IV and more.\n* Patients with a height of less than 150 cm.\n* Patients on alpha-two antagonist ACE inhibitors and CCB.\n* Patient received intrathecal morphine, intravascular dexamethasone, or Midazolam\n* Patient who can't tolerate fluid challenge. Example: ESRD, HF…etc.\n* Any contraindication for neuraxial procedure. Examples: coagulopathy, severe AS, sepsis…etc.\n* Psychiatric patients.",true,"ALL","18 Years","80 Years",{"count":80,"type":81},75,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.",[87],"Spinal Anesthesia Evaluation",[89,90,91,92],"dexmedetomedine","intrathecal dexmedetomedine","intravenous dexmedetomedine","spinal anesthesia prolongation","NOT_YET_RECRUITING","2025-01-07",{"date":96,"type":97},"2025-01-10","ACTUAL",{"date":99,"type":81},"2025-03-01",{"date":101,"type":81},"2025-09-01",{"name":5,"class":6},1]