About this trial
This randomized controlled study aims to compare the intraoperative hemodynamic effects of unilateral and bilateral spinal anesthesia in elderly patients undergoing elective total hip arthroplasty. Seventy-four patients aged 65 years and older will be randomized into two groups: unilateral spinal anesthesia (n=37) and bilateral spinal anesthesia (n=37).
Hemodynamic parameters including cardiac output, stroke volume, stroke volume variation, pulse pressure variation, and systemic vascular resistance will be continuously monitored using the Pressure Recording Analytical Method (PRAM)-based MostCare monitoring system. Intraoperative fluid requirements and vasopressor consumption will also be evaluated.
The study seeks to determine whether unilateral spinal anesthesia provides greater hemodynamic stability and reduces the need for fluid administration and vasopressor support compared with conventional bilateral spinal anesthesia in elderly patients undergoing hip arthroplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 65 years and older.
Patients scheduled for elective total hip arthroplasty.
Patients with an American Society of Anesthesiologists (ASA) physical status classification of II, III, or IV.
Patients with a Glasgow Coma Scale (GCS) score of 13-15 who are conscious and able to cooperate.
Disqualifiers
Glasgow Coma Scale (GCS) score <13.
Age below 65 years.
History of previous major neurosurgical intervention.
Anatomical abnormality, vascular defect, or infection at the site intended for arterial catheter placement for PRAM monitoring.
Trial design
Parallel
Treatments tested in this trial
Unilateral Spinal Anesthesia
Procedure/SurgeryUnilateral spinal anesthesia administered for unilateral lower extremity surgery.
Bilateral Spinal Anesthesia
Procedure/SurgeryBilateral spinal anesthesia administered for unilateral lower extremity surgery.
Treatment groups
Trial outcomes
Primary outcomes
Cardiac Index Measured Using PRAM During Spinal Anesthesia
Cardiac index will be measured using the Pressure Recording Analytical Method (PRAM) and reported in L/min/m². Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
Stroke Volume Index Measured Using PRAM During Spinal Anesthesia
Stroke volume index will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mL/beat/m². Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
Stroke Volume Variation Measured Using PRAM During Spinal Anesthesia
Stroke volume variation will be measured using the Pressure Recording Analytical Method (PRAM) and reported as a percentage. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
Pulse Pressure Variation Measured Using PRAM During Spinal Anesthesia
Pulse pressure variation will be measured using the Pressure Recording Analytical Method (PRAM) and reported as a percentage. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
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