Anesthesia, SpinalNCT06479512
Caval-aorta Index and Perfusion Index on Predict Hypotension After Spinal Anaesthesia in Elderly
An observational study of Anesthesia, Spinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal
- What is being tested?
- ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 25 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients over 60 years of age who will undergo elective lower extremity surgery in supine position admitted to ankara city hospital
Who may be able to join
- American Society of Anesthesiology(ASA) I-II-III score
- Patients over 60 years
- Elective surgeries
- Surgeries in supine position
Who cannot join
- Patient refusal to participate in the study
- The patient will undergo emergency surgery
- Contraindication to spinal anaesthesia
- Planning unilateral spinal anaesthesia
- Failure of spinal anaesthesia
- Body mass index above 35kg/m2
Show all 10Show fewer
- Presence of preoperative hypotension (SBP<90mmHg or MAP<60mmHg)
- The patient has valvular disease and arrhythmia impairing haemodynamics
- Presence of neuropsychiatric disorders that make communication difficult
- Presence of abdominal hernia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, Çankaya, Turkey, 06800, 06800
About this study
Official title: Can Caval-aorta Index and Perfusion Index Predict Hypotension After Spinal Anaesthesia in Elderly Patients Undergoing Lower Extremity Surgery?
The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia.
Read the detailed description
The study will include 200 patients over 60 years of age who are planned to undergo elective lower extremity surgery in the supine position with spinal anaesthesia. This study is planned as a single-centre prospective observational study. All patients planned to be included in the study will be fasted according to the standard protocol. Age, height, body weight, body mass index, gender, type of surgery, systemic disease, preoperative heart rate (HR), noninvasive systolic (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and peripheral oxygen saturation (SpO₂) will be measured and noted in the waiting area before entering the operating room. For the initial perfusion index (PI) value, PI measurement will be taken 3 times at 5 minutes intervals with a probe to be attached to the same finger and the average will be recorded as the initial PI value. To measure the IVC diameter, the maximum internal AP diameter of the IVC will be measured in M-mode during expiration and the mean will be taken. The maximum internal AP diameter of the abdominal aorta will be measured during systole and the mean will be recorded as the aortic diameter.The study will be explained to all patients participating in the study and informed consent will be obtained from the patients. Routine preoperative preparations and monitoring of the patients admitted to the operating room will be performed. Spinal anaesthesia will be performed through L3-4 or L4-5 intervertebral spaces in the sitting position.Depending on the nature of the patient and the type of surgery, an appropriate dose of 0.5% hyperbaric bupivacaine will be injected intrathecally to provide adequate sensory block.The patient will be immediately placed in the supine position.The level of sensory blockade will be evaluated at the end of the appropriate time. heart rate, systolic, diastolic blood pressure, mean arterial pressure, oxygen saturation and PI will be recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation.Hypotension after spinal anaesthesia will be defined as SDB less than 90 mmHg, a fall in SDB by more than 30% from the preoperative baseline value or an OAB less than 60 mmHg.Patients will be divided into two groups as patients with and without hypotension after spinal anaesthesia. Demographic data (age, gender, comorbidity, etc.), caval-aorta index and PI will be analysed for differences between the groups.
The primary aim of the study was to evaluate the ability of caval-aorta index and PI to predict post-spinal hypotension in elderly patients between the two groups.
- Conditions
- Anesthesia, Spinal
- Being tested
- ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index
- Keywords
- spinal anesthesia, caval aorta index, perfusion index, orthopedic surgery, elderly patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion indexDevice
Inferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry
| Study group | Role | What they receive |
|---|---|---|
| patients with spinal induced hypotension | patients with hypotension after spinal anesthesia (SBP less than 90 mmHg, a decrease in SBP by more than 30% from the preoperative baseline value, or an MAP below 60 mmHg) Receives: Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index | |
| patients without spinal induced hypotension | patients without spinal induced hypotension Receives: Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index |
What is being measured
The primary outcome is the main question the study is designed to answer.
caval aorta index for predicting hypotension in the elderly
to determine the threshold value for the caval aorta index in determining hypotension using logistic regression analysis
Measured: 1 hour
Secondary outcomes (12)
perfusion index for predicting hypotension in the elderly
to determine the threshold value for the perfusion index in determining hypotension using logistic regression analysis
Measured: 1 hour
inferior vena cava diameter for predicting hypotension in the elderly
to determine the threshold value for the inferior vena cava diameter in determining hypotension using logistic regression analysis
Measured: 1 hour
abdominal aort diameter for predicting hypotension in the elderly
To determine the effect of abdominal aort diameter on the prediction of hypotension using logistic regression analysis.
Measured: 1 hour
systolic blood pressure
recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation
Measured: 1 hour
diastolic blood pressure
recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation
Measured: 1 hour
mean arterial pressure
recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation
Measured: 1 hour
hearth rate
recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation
Measured: 1 hour
oxygen saturation
recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation
Measured: 1 hour
bromage scale motor blocage score
bromage scale score is a score between 0 and 3. bromage 0 means full movement of the leg and knee, bromage 3 means full motor blockade of the legs. the time to reach bromage 3 will be recorded
Measured: 1 hour
T10 dermatome
time to reach T10 dermatome level
Measured: 1 hour
dermatomal level
the highest dermatome level achieved with spinal anesthesia
Measured: 1 hour
use ephedrine
dose of ephedrine used
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Jul 2024
- Primary completion15 Apr 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479512
- Sponsor's protocol ID
- spinal-induced hypotension
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Caval-aorta Index and Perfusion Index Predict Hypotension After Spinal Anaesthesia in Elderly Patients Undergoing Lower Extremity Surgery?
- ClinicalTrials.gov ID
- NCT06479512
- Acronym / sponsor ID
- spinal-induced hypotension
- Conditions
- Anesthesia, Spinal
- Keywords
- spinal anesthesia, caval aorta index, perfusion index, orthopedic surgery, elderly patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 28 Jun 2024 (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.
The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia.
Detailed description
The study will include 200 patients over 60 years of age who are planned to undergo elective lower extremity surgery in the supine position with spinal anaesthesia. This study is planned as a single-centre prospective observational study. All patients planned to be included in the study will be fasted according to the standard protocol. Age, height, body weight, body mass index, gender, type of surgery, systemic disease, preoperative heart rate (HR), noninvasive systolic (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and peripheral oxygen saturation (SpO₂) will be measured and noted in the waiting area before entering the operating room. For the initial perfusion index (PI) value, PI measurement will be taken 3 times at 5 minutes intervals with a probe to be attached to the same finger and the average will be recorded as the initial PI value. To measure the IVC diameter, the maximum internal AP diameter of the IVC will be measured in M-mode during expiration and the mean will be taken. The maximum internal AP diameter of the abdominal aorta will be measured during systole and the mean will be recorded as the aortic diameter.The study will be explained to all patients participating in the study and informed consent will be obtained from the patients. Routine preoperative preparations and monitoring of the patients admitted to the operating room will be performed. Spinal anaesthesia will be performed through L3-4 or L4-5 intervertebral spaces in the sitting position.Depending on the nature of the patient and the type of surgery, an appropriate dose of 0.5% hyperbaric bupivacaine will be injected intrathecally to provide adequate sensory block.The patient will be immediately placed in the supine position.The level of sensory blockade will be evaluated at the end of the appropriate time. heart rate, systolic, diastolic blood pressure, mean arterial pressure, oxygen saturation and PI will be recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation.Hypotension after spinal anaesthesia will be defined as SDB less than 90 mmHg, a fall in SDB by more than 30% from the preoperative baseline value or an OAB less than 60 mmHg.Patients will be divided into two groups as patients with and without hypotension after spinal anaesthesia. Demographic data (age, gender, comorbidity, etc.), caval-aorta index and PI will be analysed for differences between the groups.
The primary aim of the study was to evaluate the ability of caval-aorta index and PI to predict post-spinal hypotension in elderly patients between the two groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with spinal induced hypotension | – | Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion indexpatients with hypotension after spinal anesthesia (SBP less than 90 mmHg, a decrease in SBP by more than 30% from the preoperative baseline value, or an MAP below 60 mmHg) |
| patients without spinal induced hypotension | – | Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion indexpatients without spinal induced hypotension |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 60 years of age who will undergo elective lower extremity surgery in supine position admitted to ankara city hospital
Key inclusion criteria (4 listed)
- American Society of Anesthesiology(ASA) I-II-III score
- Patients over 60 years
- Elective surgeries
- Surgeries in supine position
Key exclusion criteria (10 listed)
- Patient refusal to participate in the study
- The patient will undergo emergency surgery
- Contraindication to spinal anaesthesia
- Planning unilateral spinal anaesthesia
- Failure of spinal anaesthesia
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 |
|---|---|---|
| ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion indexInferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry | Device | patients with spinal induced hypotension, patients without spinal induced hypotension |
Primary outcome
caval aorta index for predicting hypotension in the elderly
Time frame: 1 hour
to determine the threshold value for the caval aorta index in determining hypotension using logistic regression analysis
12 secondary outcomes
perfusion index for predicting hypotension in the elderly
Time frame: 1 hour
inferior vena cava diameter for predicting hypotension in the elderly
Time frame: 1 hour
abdominal aort diameter for predicting hypotension in the elderly
Time frame: 1 hour
systolic blood pressure
Time frame: 1 hour
diastolic blood pressure
Time frame: 1 hour
mean arterial pressure
Time frame: 1 hour
hearth rate
Time frame: 1 hour
oxygen saturation
Time frame: 1 hour
bromage scale motor blocage score
Time frame: 1 hour
T10 dermatome
Time frame: 1 hour
dermatomal level
Time frame: 1 hour
use ephedrine
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Anesthesia, Spinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 10 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: finished, as of the sponsor's last update on 26 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caval aorta index for predicting hypotension in the elderly (time frame: 1 hour). 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 26 Dec 2025.