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NCT07684989
Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia
Conditions: Anesthesia, Spinal, Orthopedic Procedures, Postoperative Recovery in Elderly Patients, Hemodynamics, Bupivacaine
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 180
Sponsor: Mayo Hospital Lahore
Location: Mayo Hospital, Lahore Lahore Punjab Province
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.
Eligibility Criteria
Inclusion Criteria:
* Male or female patients aged 65 years and above.
* Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia.
* American Society of Anesthesiologists (ASA) physical status I-III.
* Patients willing to participate and provide written informed consent.
Exclusion Criteria:
* Refusal to participate in the study.
* Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure).
* Known hypersensitivity or allergy to bupivacaine.
* Severe valvular heart disease.
* Significant cardiac arrhythmias.
* Uncontrolled hypertension.
* Severe hepatic or renal impairment.
* Pre-existing neurological disorders affecting lower limb motor or sensory function.
* Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia.
* Cognitive impairment or inability to provide informed consent.
* Emergency orthopedic procedures.
Source: ClinicalTrials.gov (NCT07684989). StuddyBuddy aggregates publicly available trial information.