Hypotension After Spinal AnesthesiaNCT07876063
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
An observational study of Hypotension After Spinal Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
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: The predictive performance of preoperative CFTc for post-spinal hypotension . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension After Spinal Anesthesia
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2026to 30 Sep 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- Patients aged 65 years or older
- Both sexes
- Scheduled for elective hip replacement surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III
Who cannot join
- Patient refusal to participate
- Severe carotid artery stenosis (> 50%)
- Cardiac arrhythmias
- Severe valvular heart disease
- Uncontrolled hypertension
- Hepatic or renal impairment
- Infection at the intended site of spinal injection
- Any contraindications to spinal anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alaa M Abo Hagar, M.D. contact
Egypt1 site
Faculty of Medicine, Tanta University
Tanta, Gharbia Governorate, 31527
Maha M El-Gazzar, M.Sc., +201010468790, mahamahmoud936@gmail.com
About this study
Official title: Predictability of Preoperative Carotid Artery-Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Geriatric Hip Replacement Surgery: A Prospective Observational Study
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:
Read more
- The predictive performance of preoperative CFTc for post-spinal hypotension .
Secondary outcomes:
- Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of CFTc in prediction of hypotension.
- Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of IVC collapsibility.
- Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of echocardiography (ECHO) (LVOT-VTI).
- Comparison of predictive accuracy of CFTc, IVC, and ECHO for post-spinal hypotension.
- Monitoring of systolic blood pressure (SBP), mean arterial pressure (MAP), and heart rate (HR) (first 10 min every 2 minutes, then at 15 min and at 20 min).
Read the detailed description
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.
- Conditions
- Hypotension After Spinal Anesthesia
- Being tested
- Ultrasound
- Keywords
- Post-spinal hypotension, Carotid Doppler ultrasound, Corrected carotid flow time (CFTc), Total hip arthroplasty, Hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative (Baseline, before spinal anesthesia).
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: Measured at 2, 4, 6, 8, and 10 minutes, then at 15 minutes and 20 minutes following spinal anesthesia administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension After Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mahmoud Rabee El Gazzar, Tanta University
- Investigators
- Abdelraheem M Dowidar, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876063
- Sponsor's protocol ID
- 36266MD5/8/26
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Preoperative Carotid Artery-Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Geriatric Hip Replacement Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07876063
- Acronym / sponsor ID
- 36266MD5/8/26
- Conditions
- Hypotension After Spinal Anesthesia
- Keywords
- Post-spinal hypotension, Carotid Doppler ultrasound, Corrected carotid flow time (CFTc), Total hip arthroplasty, Hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The predictive performance of preoperative CFTc for post-spinal hypotension .
Secondary outcomes:
- Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of CFTc in prediction of hypotension.
- Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of IVC collapsibility.
- Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of echocardiography (ECHO) (LVOT-VTI).
- Comparison of predictive accuracy of CFTc, IVC, and ECHO for post-spinal hypotension.
- Monitoring of systolic blood pressure (SBP), mean arterial pressure (MAP), and heart rate (HR) (first 10 min every 2 minutes, then at 15 min and at 20 min).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Patients aged 65 years or older
- Both sexes
- Scheduled for elective hip replacement surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III
Key exclusion criteria (8 listed)
- Patient refusal to participate
- Severe carotid artery stenosis (> 50%)
- Cardiac arrhythmias
- Severe valvular heart disease
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundPreoperative 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. | Device | – |
Primary outcome
Predictive Performance of Preoperative Corrected Carotid Flow Time (CFTc) for Post-Spinal Hypotension
Time frame: Preoperative (Baseline, before spinal anesthesia).
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.
6 secondary outcomes
Optimal Cut-Off Value of Corrected Carotid Flow Time (CFTc)
Time frame: Within the first 20 minutes following spinal anesthesia.
Optimal Cut-Off Value of Inferior Vena Cava Collapsibility Index (IVCCI)
Time frame: Within the first 20 minutes following spinal anesthesia.
Optimal Cut-Off Value of Left Ventricular Outflow Tract Velocity Time Integral (LVOT-VTI)
Time frame: Within the first 20 minutes following spinal anesthesia.
Comparison of Area Under the Curve (AUC) for CFTc, IVCCI, and LVOT-VTI
Time frame: Within the first 20 minutes following spinal anesthesia.
Hemodynamic Monitoring: Systolic Blood Pressure (SBP) and Mean Arterial Pressure (MAP)
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)
Time frame: Measured at 2, 4, 6, 8, and 10 minutes, then at 15 minutes and 20 minutes following spinal anesthesia administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa M Abo Hagar, M.D. contact
Abdelraheem M Dowidar, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension After Spinal Anesthesia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha M El-Gazzar, M.Sc. (+201010468790, mahamahmoud936@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Performance of Preoperative Corrected Carotid Flow Time (CFTc) for Post-Spinal Hypotension (time frame: Preoperative (Baseline, before spinal anesthesia).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.