[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053344":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":42,"interventions":55,"overallOfficials":30,"centralContacts":63,"locations":69,"responsibleParty":83,"collaborators":30,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":30,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":30,"enrollmentInfo":96,"targetDuration":30,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":114,"whyStopped":30,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Mayo Hospital Lahore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Intraoperative Hypotension","Occurrence of intraoperative hypotension following spinal anesthesia, defined as a decrease in systolic blood pressure greater than 20% from baseline or systolic blood pressure less than 90 mmHg requiring intervention.","From administration of spinal anesthesia until completion of surgery",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Incidence of Intraoperative Bradycardia","Occurrence of intraoperative bradycardia, defined as heart rate less than 50 beats per minute requiring pharmacological treatment.","From administration of spinal anesthesia until completion of surgery.",{"measure":19,"description":20,"timeFrame":21},"Time to Complete Motor Recovery","Time required to achieve complete motor recovery following spinal anesthesia, assessed using Bromage Score 0.","From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively",{"measure":23,"description":24,"timeFrame":25},"Time to First Ambulation","Time from completion of surgery to the patient's first assisted ambulation.","Within the first 24 hours after surgery",{"measure":27,"description":28,"timeFrame":29},"Postoperative Recovery Profile","Assessment of recovery following spinal anesthesia, including readiness for discharge from the post-anesthesia care unit and return of motor function.","From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Eligible participants will be randomized into two parallel groups. One group will receive low-dose hyperbaric bupivacaine and the other will receive standard-dose hyperbaric bupivacaine for spinal anesthesia. Outcomes related to hemodynamic stability and postoperative recovery will be compared between groups.","TREATMENT",{"masking":37,"maskingDescription":38,"whoMasked":39},"DOUBLE","Participants will be unaware of the group allocation. Postoperative outcome assessment and data collection will be performed by an investigator blinded to treatment allocation. The anesthesiologist administering spinal anesthesia will not be blinded because of the preparation and administration of different doses of hyperbaric bupivacaine.",[40,41],"PARTICIPANT","OUTCOMES_ASSESSOR",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"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.",[48],"Drug: Low-Dose Hyperbaric Bupivacaine",{"label":50,"type":51,"description":52,"interventionNames":53},"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.",[54],"Drug: Standard-Dose Hyperbaric Bupivacaine",[56,60],{"type":57,"name":44,"description":58,"armGroupLabels":59,"otherNames":30},"DRUG","Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.",[44],{"type":57,"name":50,"description":61,"armGroupLabels":62,"otherNames":30},"Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.",[50],[64],{"name":65,"role":66,"phone":67,"phoneExt":30,"email":68},"Muhammad Shaheryar Bashir, MBBS, BSc, FCPS (R) CHPE, DPHN","CONTACT","+92-335-4377900","drmsb259@gmail.com",[70],{"facility":71,"status":30,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":30},"Mayo Hospital, Lahore","Lahore","Punjab Province","54950","Pakistan","PK",{"type":78,"coordinates":79},"Point",[80,81],74.35071,31.558,{"lat":81,"lon":80},{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"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":97,"type":98},180,"ESTIMATED","INTERVENTIONAL",[101],"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.",[104,105,106,107,108],"Anesthesia, Spinal","Orthopedic Procedures","Postoperative Recovery in Elderly Patients","Hemodynamics","Bupivacaine",[44,50,110,111,112,113],"Spinal Anesthesia","Geriatric Anesthesia","Lower Limb Orthopedic Surgery","Hemodynamic Stability","NOT_YET_RECRUITING","2026-07-10",{"date":117,"type":118},"2026-07-13","ACTUAL",{"date":120,"type":98},"2026-07-01",{"date":122,"type":98},"2027-06-30",{"name":5,"class":6},1]