Comparison of the Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia in Hip Arthroplasty Surgeries in Elderly Patients Using the Continuous Pressure Recording Analytical Method.
Sponsor study identifier
interventional
74
1 country
1
Study Start
May 1, 2026
Actual (reported)Primary Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2026
Actual (reported)June 11, 2026
Actual (reported)August 27, 2026
Actual (reported)August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Patients receive unilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery.
Patients receive bilateral spinal anesthesia and hemodynamic parameters are monitored using the PRAM method during surgery.
Unilateral spinal anesthesia administered for unilateral lower extremity surgery.
Bilateral spinal anesthesia administered for unilateral lower extremity surgery.
Kayseri City Hospital
Kayseri, Kayseri, Turkey (Türkiye)
First Submitted
June 11, 2026
First Posted
August 27, 2026
Study Start
May 1, 2026
Actual (reported)Primary Completion
August 31, 2026
Estimated (date passed)Comparison of the Efficacy of Conventional Landmark, Ultrasound-Assisted, and Real-Time Ultrasound-Guided Techniques in Spinal Anesthesia for Obese Patients
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.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
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.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Systemic Vascular Resistance Measured Using PRAM During Spinal Anesthesia
Systemic vascular resistance will be measured using the Pressure Recording Analytical Method (PRAM) and reported in dyn·s/cm⁵. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Oxygen Delivery Index Measured Using PRAM During Spinal Anesthesia
Oxygen delivery index will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mL/min/m². Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Arterial Elastance Measured Using PRAM During Spinal Anesthesia
Arterial elastance will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mmHg/mL. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Maximum Rate of Arterial Pressure Rise Measured Using PRAM
The maximum rate of arterial pressure rise (dP/dtmax) will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mmHg/s. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Cardiac Cycle Efficiency Measured Using PRAM
Cardiac cycle efficiency (CCE) will be measured using the Pressure Recording Analytical Method (PRAM) and reported as a dimensionless value. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Oxygen Delivery Measured Using PRAM During Spinal Anesthesia
Oxygen delivery (DO₂) will be measured using the Pressure Recording Analytical Method (PRAM) and reported in mL/min. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Mean Arterial Pressure During Spinal Anesthesia
Mean arterial pressure (MAP) will be measured using invasive arterial pressure monitoring and reported in mmHg. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Heart Rate During Spinal Anesthesia
Heart rate (HR) will be recorded using standard perioperative monitoring and reported in beats per minute. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Peripheral Oxygen Saturation During Spinal Anesthesia
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage. Measurements recorded at each study time point will be compared between the unilateral and bilateral spinal anesthesia groups.
From immediately before spinal anesthesia until completion of surgery, assessed at baseline and every 10 minutes for up to 180 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 27, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: