An observational study in Hypotension After Spinal Anesthesia, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Tanta University · Observational
This study aims to evaluate the predictability of preoperative carotid artery-corrected flow time (CFTc) for hypotension after spinal anesthesia in patients undergoing geriatric hip replacement surgery.
Primary outcomes:
Secondary outcomes:
Hip osteoarthritis (OA) is one of the most common types of arthritis. Common symptoms of hip OA include joint pain, swelling, stiffness, and limited mobility. Early intervention can help slow the progression of the disease and improve the quality of life for patients. Total hip arthroplasty (THA) is among the five most commonly performed surgical procedures worldwide. It is a functional prosthetic intervention involving the replacement of a damaged joint.
This surgery can be performed under either general anesthesia (GA) or regional anesthesia (most commonly spinal anesthesia). Key factors influencing morbidity and mortality include preoperative assessment, anesthetic technique selection, intraoperative management, and postoperative care. Hypotension is the most common side effect associated with spinal anesthesia. The likely mechanism involves spinal nerve sympathectomy, which leads to peripheral arterial vasodilation, reduced venous return, and, consequently, a decrease in cardiac output.
The main cause of spinal anesthesia-induced hypotension (SAH) is sympathetic blockade, which results in vasodilation with relative hypovolemia and reduced cardiac output. Many elderly patients arrive at the operating room in a relatively hypovolemic state due to preoperative fasting, reduced thirst mechanisms, and diminished renal capacity to conserve water and salt.
Traditional approaches to post spinal anesthesia hypotension (PSAH) prevention have demonstrated limitations. Fluid boluses fail to adequately increase cardiac volume in approximately 50% of hemodynamically unstable patients, and in fluid non-responsive individuals, such empirical loading may even exacerbate the patient's condition. The absence of a definitive tool to reliably predict PSAH makes it challenging to differentiate patients who would benefit from vasopressors versus those who would respond to fluid boluses.
The ongoing quest for simple, reliable, and non-invasive methods to predict PSAH has led to the exploration of various ultrasonographic parameters. While techniques like transthoracic bioimpedance and transthoracic echocardiography (TTE) offer insights into hemodynamic status, TTE demands high operator proficiency and is time-consuming, and bioimpedance devices are often expensive and not readily available. In contrast, ultrasonographic assessment of the inferior vena cava collapsibility index (IVCCI) and corrected carotid flow time (CFTc) have emerged as potentially time efficient, easy-to-perform, and widely available indicators of fluid responsiveness, capable of identifying changes in cardiac output.
The IVC diameter provides an indirect assessment of intravascular volume. Preoperative IVCCI has been proposed as a dependable indicator for predicting the likelihood of hypotension within 30 minutes following spinal anesthesia. Similarly, CFTc, which represents the carotid systole time corrected for heart rate, is a simple measurement that may correlate with intravascular volume, with fluid administration increasing CFTc and volume depletion decreasing it.
However, direct comparative studies evaluating the efficacy of both CFTc and IVCCI in predicting PSAH, particularly in the geriatric population, have been scarce. Therefore, this study is designed to evaluate the predictive value of preoperative CFTc for hypotension after spinal anesthesia in patients undergoing geriatric hip surgery.
Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Geriatric patients aged 65 years and older of either sex scheduled for elective hip replacement surgery under spinal anesthesia at the Anesthesia Department of Tanta University Hospital.
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Exclusion Criteria:
Preoperative point-of-care ultrasonography is performed using a diagnostic ultrasound system (SONY, General Electric (GE) Medical Systems) to evaluate baseline intravascular volume and hemodynamic status before spinal anesthesia. A high-frequency linear ultrasound probe is positioned over the common carotid artery proximal to its bifurcation to record pulsed-wave Doppler waveforms, measuring flow time from systolic upstroke to the dicrotic notch and calculating the corrected carotid flow time (CFTc) using Wodey's formula across three averaged cycles. The ultrasound device is additionally used with a 2-4 megahertz (MHz) transducer to measure the inferior vena cava collapsibility index (IVCCI) via subcostal M-mode imaging during an inspiratory sniff, as well as the left ventricular outflow tract velocity time integral (LVOT-VTI) via apical five-chamber echocardiography, to determine their accuracy in predicting post-spinal anesthesia hypotension.
Predictive Performance of Preoperative Corrected Carotid Flow Time (CFTc) for Post-Spinal Hypotension
Carotid flow time is measured preoperatively via pulsed-wave Doppler ultrasound of the common carotid artery. A high-frequency linear ultrasound probe is positioned over the common carotid artery proximal to its bifurcation. The flow time is measured from the systolic upstroke to the dicrotic notch and is then corrected for heart rate using Wodey's formula across three averaged cycles.
Time frame: Preoperative (Baseline, before spinal anesthesia).
Optimal Cut-Off Value of Corrected Carotid Flow Time (CFTc)
Evaluation of the diagnostic performance of preoperative CFTc to predict post-spinal anesthesia hypotension. CFTc is measured preoperatively via pulsed-wave Doppler ultrasound of the common carotid artery and corrected using Wodey's formula. Hypotension is defined as a reduction in systolic blood pressure (SBP) greater than 20% from baseline or a mean arterial pressure (MAP) \< 65 mmHg.
Time frame: Within the first 20 minutes following spinal anesthesia.
Optimal Cut-Off Value of Inferior Vena Cava Collapsibility Index (IVCCI)
Evaluation of the diagnostic performance of preoperative IVCCI to predict post-spinal anesthesia hypotension. IVCCI is assessed preoperatively using subcostal M-mode ultrasonography during an inspiratory sniff.
Time frame: Within the first 20 minutes following spinal anesthesia.
Optimal Cut-Off Value of Left Ventricular Outflow Tract Velocity Time Integral (LVOT-VTI)
Evaluation of the diagnostic performance of preoperative LVOT-VTI to predict post-spinal anesthesia hypotension. LVOT-VTI is measured preoperatively via apical five-chamber echocardiography.
Time frame: Within the first 20 minutes following spinal anesthesia.
Comparison of Area Under the Curve (AUC) for CFTc, IVCCI, and LVOT-VTI
The predictive accuracy of CFTc, IVCCI, and LVOT-VTI for post-spinal hypotension will be compared using Receiver Operating Characteristic (ROC) curve analysis to contrast their respective Areas Under the Curve (AUC).
Time frame: Within the first 20 minutes following spinal anesthesia.
Hemodynamic Monitoring: Systolic Blood Pressure (SBP) and Mean Arterial Pressure (MAP)
Continuous monitoring of blood pressure following the administration of spinal anesthesia to evaluate hemodynamic stability and detect hypotension. Unit of Measure: mmHg
Time frame: Measured at 2, 4, 6, 8, and 10 minutes, then at 15 minutes and 20 minutes following spinal anesthesia administration.
Hemodynamic Monitoring: Heart Rate (HR)
Continuous monitoring of heart rate following the administration of spinal anesthesia to evaluate hemodynamic stability. Unit of Measure: Beats per minute
Time frame: Measured at 2, 4, 6, 8, and 10 minutes, then at 15 minutes and 20 minutes following spinal anesthesia administration.
Plan to share: No — Individual participant data will not be made publicly available due to patient privacy and data confidentiality agreements. However, de-identified data may be made available to qualified researchers upon reasonable request to the corresponding author, subject to approval by the institutional ethics committee.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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