[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618342":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":27,"responsibleParty":42,"collaborators":27,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":27,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":27,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":72,"whyStopped":27,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":27},{"fullName":5,"class":6},"Zagazig University","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group D+K (Dexmedetomidine-Ketamine Combination)","ACTIVE_COMPARATOR","Patients will receive intravenous dexmedetomidine (drug 1) loading dose of 0.5 µg\u002Fkg diluted with normal saline to a volume of 10 ml solution over 10 min (started when a sensory level of T10 was achieved) Maintenance dose of 0.5 µg\u002Fkg\u002Fh infusion and Intravenous ketamine (drug 2) loading dose of 0.2mg\u002Fkg diluted with normal saline to a volume of 10 ml solution over 2-3min ( started when a sensory level of T10 was achieved) maintenance dose of 0.2 mg\u002Fkg\u002Fh infusion.\n\nIn both groups, drug 1 will be titrated by 0.1 µg\u002Fkg\u002Fh every 30 min to maintain a Ramsay Sedation Scale (RSS) score of 3-4.\n\nIf the RSS score was \\>4 at 0.2 µg\u002Fkg\u002Fh of Drug 1, both drug infusions will be stopped.The drug infusions will be restarted at the lowest doses at RSS of 3.",[13,14],"Drug: Dexmedetomidine","Drug: Ketamine",{"label":16,"type":17,"description":18,"interventionNames":19},"Dexmedetomidine group (D)","PLACEBO_COMPARATOR","Patients will receive intravenous dexmedetomidine (drug 1) loading dose of 0.5 µg\u002Fkg diluted with normal saline to a volume of10 ml solution over 10 min (started when a sensory level of T10 was achieved) Maintenance dose of 0.5 µg\u002Fkg\u002Fh and intravenous normal saline (drug 2) loading dose 10ml of solution over 2-3min ( started when a sensory level of T10 was achieved) and a maintenance dose of 0.2 mg\u002Fkg\u002Fh as placebo.\n\nIn both groups, drug 1 will be titrated by 0.1 µg\u002Fkg\u002Fh every 30 min to maintain a Ramsay Sedation Scale (RSS) score of 3-4. If the RSS score \\>4 at 0.2 µg\u002Fkg\u002Fh of Drug 1, both drug infusions will be stopped.The drug infusions will be restarted at the lowest doses at RSS of 3.",[13,20],"Drug: Saline (0.9% NaCl)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Dexmedetomidine","Intravenous dexmedetomidine 0.5 µg\u002Fkg diluted with normal saline to a volume of 10 ml solution over 10 min followed by 0.5 µg\u002Fkg\u002Fh infusion.",[16,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Ketamine","Intravenous ketamine 0.2 mg\u002Fkg diluted with normal saline to a volume of 10 ml solution over 2-3 min followed by 0.2 mg\u002Fkg\u002Fhr infusion.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Saline (0.9% NaCl)","intravenous normal saline 10ml of solution over 2-3min followed by 0.2 mg\u002Fkg\u002Fhr infusion as placebo",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Abdelrahman Elsayed Amer, Resident of Anesthesia","CONTACT","00201024172506","ae.amer025@medicine.zu.edu.eg",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","abdelrahman elsayed abdelrahman elsayed saad amer","Resident of Anesthesia, Intensive Care and Pain management","100618342","phase-3-effect-of-intravenous-dexmedetomidine-and-ketamine-on-post-operative-analgesia-100618342",false,"NCT07330375","Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia","The Effect of Intravenous Combination Dexmedetomidine - Ketamine Versus Dexmedetomidine on Post-Operative Analgesia in Patients Undergoing Vaginal Hysterectomy Under Spinal Anesthesia","Inclusion Criteria:\n\n* Patients who will accept written informed consent.\n* Age: 21-65 years old.\n* Sex: female.\n* BMI: \\\u003C35 kg\u002Fm2\n* Physical status: American Society of Anesthesiology (ASA) of Grade I-II\n* Type of operation: vaginal hysterectomy under spinal anesthesia.\n\nExclusion Criteria:\n\n* Uncooperative patients\n* Any contraindication for spinal anesthesia e.g. coagulopathy, infection at site of block, and hypersensitivity to any drug used in this study.\n* Patients who are known to be drug dependent.",true,"FEMALE","21 Years","65 Years",{"count":58,"type":59},50,"ESTIMATED","INTERVENTIONAL",[62],"PHASE3","In this study the participants aim to Compare The Effect of Intravenous Combination Dexmedetomidine \\_ Ketamine versus Dexmedetomidine on Post-Operative Analgesia In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.",[65,66],"Postoperative Analgesia","Postoperative Pain Management",[68,69,70,71],"spinal anesthesia","vaginal hysterectomy","dexmedetomidine","ketamine","NOT_YET_RECRUITING","2025-12-28",{"date":75,"type":76},"2026-01-09","ACTUAL",{"date":78,"type":59},"2026-01-20",{"date":80,"type":59},"2026-06-30",{"name":5,"class":6}]