[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053344":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":25,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Mayo Hospital Lahore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Dose Hyperbaric Bupivacaine","EXPERIMENTAL","Participants randomized to this group will receive low-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol.",[13],"Drug: Low-Dose Hyperbaric Bupivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard-Dose Hyperbaric Bupivacaine","ACTIVE_COMPARATOR","Participants randomized to this group will receive standard-dose hyperbaric bupivacaine for spinal anesthesia before elective lower limb orthopedic surgery. Hemodynamic parameters and postoperative recovery outcomes will be assessed according to the study protocol.",[19],"Drug: Standard-Dose Hyperbaric Bupivacaine",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN","CONTACT","+92-335-4377900","drmsb259@gmail.com",[36],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":25},"Mayo Hospital, Lahore","Lahore","Punjab Province","54950","Pakistan","PK",{"type":44,"coordinates":45},"Point",[46,47],74.35071,31.558,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Muhammad Shaheryar Bashir","Principal Investigator","100053344","phase-4-comparison-of-low-dose-versus-standard-dose-hyperbaric-bupivacaine-in-spinal-anesthesia-100053344",false,"NCT07684989","Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia","Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia: Hemodynamic Stability and Recovery Profile in Elderly Patients Undergoing Lower Limb Orthopedic Surgery","Inclusion Criteria:\n\n* Male or female patients aged 65 years and above.\n* Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Patients willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure).\n* Known hypersensitivity or allergy to bupivacaine.\n* Severe valvular heart disease.\n* Significant cardiac arrhythmias.\n* Uncontrolled hypertension.\n* Severe hepatic or renal impairment.\n* Pre-existing neurological disorders affecting lower limb motor or sensory function.\n* Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia.\n* Cognitive impairment or inability to provide informed consent.\n* Emergency orthopedic procedures.","ALL","65 Years",{"count":63,"type":64},180,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia.\n\nThe main questions it aims to answer are:\n\n* Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine?\n* Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine?\n\nResearchers will compare elderly patients receiving low-dose hyperbaric bupivacaine with those receiving standard-dose hyperbaric bupivacaine to determine whether a lower intrathecal dose improves cardiovascular stability and recovery without compromising the effectiveness of spinal anesthesia.\n\nParticipants will:\n\n* Provide written informed consent before enrollment.\n* Undergo elective lower limb orthopedic surgery under spinal anesthesia.\n* Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine.\n* Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure.\n* Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria.\n* Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization.\n\nThe information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.",[70,71,72,73,74],"Anesthesia, Spinal","Orthopedic Procedures","Postoperative Recovery in Elderly Patients","Hemodynamics","Bupivacaine",[9,15,76,77,78,79],"Spinal Anesthesia","Geriatric Anesthesia","Lower Limb Orthopedic Surgery","Hemodynamic Stability","NOT_YET_RECRUITING","2026-07-10",{"date":83,"type":84},"2026-07-13","ACTUAL",{"date":86,"type":64},"2026-07-01",{"date":88,"type":64},"2027-06-30",{"name":5,"class":6},1]