- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06905535
Corrected Carotid Flow Time for Predicting Spinal Anesthesia-induced Hypotension
The Effect of Carotid Corrected Blood Flow Time Measured in the Left Lateral Tilt Position on the Prediction of Spinal Anaesthesia-induced Hypotension in Caesarean Section
Study Overview
Status
Conditions
Detailed Description
Patients undergoing elective cesarean section under spinal anesthesia will be included in the study. Carotid corrected flow time will be measured by Doppler ultrasonography in the supine and left lateral tilt (15°) positions before spinal anesthesia. Flow time will be measured using pulse Doppler waveforms in the long axis of the right common carotid artery. The measured flow time will be calculated as "corrected flow time" using the following Wodey formula; Carotid corrected flow time = measured flow time + [1.29 (Heart rate - 60)].
After standard monitoring (Electrocardiography, peripheral oxygen saturation, noninvasive blood pressure measurement), routine spinal anesthesia will be performed without any study-specific changes. The noninvasive blood pressure value measured before spinal anesthesia will be taken as the baseline value and a decrease of 20% or more in this value or a decrease in systolic blood pressure below 100 mmHg will be considered as "spinal anesthesia induced hypotension". Patients will be divided into those who develop spinal anesthesia-induced hypotension and those who do not develop spinal anesthesia-induced hypotension after spinal anesthesia and carotid corrected flow times will be compared between both groups.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Full-term pregnancy
- physical status II of American Society of Anesthesiologists
Exclusion Criteria:
- emergency cesarean section,
- cesarean under general anesthesia
- gestational Diabetes Mellitus
- gestational Hypertension
- preeclampsia,
- cardiovascular disease
- cerebrovascular disease
- chronic kidney disease disease
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
predictive value of the carotid flow time alteration
Time Frame: 10-15 minute
|
rate of prediction
|
10-15 minute
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- carotis flow
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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