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Completed

NCT Number: NCT06479512

Caval-aorta Index and Perfusion Index on Predict Hypotension After Spinal Anaesthesia in Elderly

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey, 06800, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiology(ASA) I-II-III score
  • Patients over 60 years
  • Elective surgeries
  • Surgeries in supine position

Exclusion criteria

  • 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
  • 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

Treatment and study plan

ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index

Device

Inferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry

Primary outcomes

  1. 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

Secondary outcomes

  1. perfusion index for predicting hypotension in the elderly

    Time frame: 1 hour

    to determine the threshold value for the perfusion index in determining hypotension using logistic regression analysis

  2. inferior vena cava diameter for predicting hypotension in the elderly

    Time frame: 1 hour

    to determine the threshold value for the inferior vena cava diameter in determining hypotension using logistic regression analysis

  3. abdominal aort diameter for predicting hypotension in the elderly

    Time frame: 1 hour

    To determine the effect of abdominal aort diameter on the prediction of hypotension using logistic regression analysis.

  4. systolic blood pressure

    Time frame: 1 hour

    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

  5. diastolic blood pressure

    Time frame: 1 hour

    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

  6. mean arterial pressure

    Time frame: 1 hour

    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

  7. hearth rate

    Time frame: 1 hour

    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

  8. oxygen saturation

    Time frame: 1 hour

    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

  9. bromage scale motor blocage score

    Time frame: 1 hour

    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

  10. T10 dermatome

    Time frame: 1 hour

    time to reach T10 dermatome level

  11. dermatomal level

    Time frame: 1 hour

    the highest dermatome level achieved with spinal anesthesia

  12. use ephedrine

    Time frame: 1 hour

    dose of ephedrine used

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Can Caval-aorta Index and Perfusion Index Predict Hypotension After Spinal Anaesthesia in Elderly Patients Undergoing Lower Extremity Surgery?

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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