Clinical Trial

Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia

Not Yet Recruiting Phase 4
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Summary
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. The main questions it aims to answer are: * Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine? * Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine? Researchers 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. Participants will: * Provide written informed consent before enrollment. * Undergo elective lower limb orthopedic surgery under spinal anesthesia. * Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine. * Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure. * Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria. * Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization. The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.
Protocol Amendment History 1 change
notable Sponsor changed: Holy Family Hospital, Pakistan -> Mayo Hospital Lahore 2026-07-14
Trial Details
NCT Number NCT07684989
Lead Sponsor Mayo Hospital Lahore
Conditions Anesthesia, Spinal, Orthopedic Procedures, Postoperative Recovery in Elderly Patients, Hemodynamics, Bupivacaine
Enrollment 180 participants
Start Date 2026-07-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13