- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06479512
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?
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Çankaya, Turkey, 06800
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Ankara, Ankara, Çankaya, Turkey, 06800, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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)
|
Inferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry
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|
patients without spinal induced hypotension
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Inferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 hour
|
|
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
|
1 hour
|
|
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
|
1 hour
|
|
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
|
1 hour
|
|
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
|
1 hour
|
|
T10 dermatome
Time Frame: 1 hour
|
time to reach T10 dermatome level
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1 hour
|
|
dermatomal level
Time Frame: 1 hour
|
the highest dermatome level achieved with spinal anesthesia
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1 hour
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use ephedrine
Time Frame: 1 hour
|
dose of ephedrine used
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1 hour
|
|
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
|
1 hour
|
|
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
|
1 hour
|
|
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
|
1 hour
|
|
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.
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- spinal-induced hypotension
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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