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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06479512
Study groupRoleWhat they receive
patients with spinal induced hypotensionpatients 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 hypotensionpatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. T10 dermatome

    time to reach T10 dermatome level

    Measured: 1 hour

  11. dermatomal level

    the highest dermatome level achieved with spinal anesthesia

    Measured: 1 hour

  12. 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.

  1. First posted28 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion15 Apr 2025
  4. Study completion25 May 2025

Resources

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)
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

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.

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