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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06479512
Enrollment
200
Registered
2024-06-28
Start date
2024-07-01
Completion date
2025-05-25
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal

Keywords

spinal anesthesia, caval aorta index, perfusion index, orthopedic surgery, elderly patients

Brief 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.

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.

Interventions

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

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
caval aorta index for predicting hypotension in the elderly1 hourto determine the threshold value for the caval aorta index in determining hypotension using logistic regression analysis

Secondary

MeasureTime frameDescription
perfusion index for predicting hypotension in the elderly1 hourto determine the threshold value for the perfusion index in determining hypotension using logistic regression analysis
inferior vena cava diameter for predicting hypotension in the elderly1 hourto determine the threshold value for the inferior vena cava diameter in determining hypotension using logistic regression analysis
abdominal aort diameter for predicting hypotension in the elderly1 hourTo determine the effect of abdominal aort diameter on the prediction of hypotension using logistic regression analysis.
systolic blood pressure1 hourrecorded 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
diastolic blood pressure1 hourrecorded 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
mean arterial pressure1 hourrecorded 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
hearth rate1 hourrecorded 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
oxygen saturation1 hourrecorded 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
bromage scale motor blocage score1 hourbromage 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
T10 dermatome1 hourtime to reach T10 dermatome level
dermatomal level1 hourthe highest dermatome level achieved with spinal anesthesia
use ephedrine1 hourdose of ephedrine used

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026