[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sedation-during-lower-extremity-surgery-under-spinal-anesthesia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sedation-during-lower-extremity-surgery-under-spinal-anesthesia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100659360","phase-4-remimazolam-concentration-and-sedation-depth-during-lower-extremity-surgery-under-spinal-anesthesia-100659360",false,"NCT07863063","Remimazolam Concentration and Sedation Depth During Lower Extremity Surgery Under Spinal Anesthesia","Relationship Between Model-Predicted Effect-Site Concentration and Sedation Depth During Titrated Remimazolam Sedation for Lower Extremity Surgery Under Spinal Anesthesia: An Age-Stratified Prospective Study","Inclusion Criteria:\n\n* Age 19 years or older.\n* Scheduled for lower extremity surgery under spinal anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Agrees to intraoperative sedation and provides written informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate.\n* Contraindication to spinal anesthesia, including refusal, increased intracranial pressure, infection at the puncture site, underlying neurological disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia, or coagulopathy.\n* Contraindication or history of hypersensitivity to remimazolam, including acute narrow-angle glaucoma, severe respiratory failure, or dextran 40 hypersensitivity.\n* Contraindication or history of hypersensitivity to flumazenil.\n* Body weight below 40 kg.\n* Baseline Modified Observer's Assessment of Alertness\u002FSedation (MOAA\u002FS) score of 4 or lower.\n* Central nervous system disease or cognitive impairment that makes MOAA\u002FS assessment unreliable.\n* Regular use of psychotropic medications, including benzodiazepines.\n* Pregnancy.\n* Other circumstances judged unsuitable by the investigator.\n\nOnly adults capable of providing informed consent are included. Employees and students are not included, as specified in the protocol.","ALL","19 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study will examine how the amount of remimazolam predicted to reach its site of action relates to the depth of sedation during lower extremity surgery under spinal anesthesia. Remimazolam is a sedative used to help patients relax and feel sleepy during surgery. People may respond differently to the same amount of this medicine, and age may explain some of these differences.\n\nSixty adults will be enrolled at Seoul National University Hospital, with 20 participants in each age group: 19-49 years, 50-69 years, and 70 years or older. All participants will receive remimazolam using the same stepwise dose-adjustment rules. The dose will be adjusted according to repeated assessments of responsiveness. Researchers will record sedation scores, medication delivery, brain-wave signals, vital signs, recovery, and side effects.\n\nAfter surgery, a computer model will estimate the remimazolam concentration at its site of action. These estimates will not be available to the clinical team during surgery. The main goal is to measure how much the concentration associated with the target level of sedation varies between patients. The study will also examine the effect of age and whether early responses can help predict an individual patient's later response.",[26],"Sedation During Lower Extremity Surgery Under Spinal Anesthesia",[28,29,30,31,32,33],"Remimazolam","Spinal anesthesia","Effect-site concentration","Sedation depth","Pharmacodynamics","Electroencephalography","NOT_YET_RECRUITING","2026-10-06",{"date":37,"type":38},"2026-10-13","ACTUAL",{"date":40,"type":20},"2026-10-30",{"date":42,"type":20},"2027-10",{"name":44,"class":45},"Seoul National University Hospital","OTHER"]