- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06749184
Predictors of Spinal Anesthesia-Induced Hypotension in Hypertensive Patients
Determining Factors That Predict Hypotension Related to Spinal Anesthesia in Patients With Hypertension
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karatay
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Konya, Karatay, Turkey (Türkiye), 42020
- Konya City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The study will include adult hypertensive patients scheduled for elective surgical procedures under spinal anesthesia at Konya City Hospital. The target population comprises patients with hypertensive patients (ASA II-III classification), who are deemed fit for elective surgery and spinal anesthesia by their clinical teams.
Eligible participants will be screened based on inclusion and exclusion criteria. The study population represents a subset of hypertensive individuals with varying durations of hypertension, medication regimens, and cardiovascular profiles. Patients will be recruited from preoperative assessment clinics and surgical wards at the hospital.
Description
Inclusion Criteria:
Adult hypertensive patients classified as ASA II-III risk group. Patients scheduled for elective surgeries requiring spinal anesthesia.
Exclusion Criteria:
Presence of severe renal or hepatic failure, or severe respiratory or cardiovascular diseases.
Contraindication to spinal anesthesia. Failure of spinal anesthesia. History of carotid surgery or presence of carotid plaques. Presence of anxiety.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Spinal Anesthesia-Induced Hypotension (SASH)
Time Frame: 30 minutes after spinal anesthesia.
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Percentage of patients experiencing a decrease in systolic blood pressure by 20% or more from baseline or a drop below 90 mmHg during the first 30 minutes following spinal anesthesia.
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30 minutes after spinal anesthesia.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Value of Internal Jugular Vein Collapsibility Index
Time Frame: Pre-anesthesia measurement.
|
The collapsibility index of the inferior vena cava (IVC) will be measured using ultrasound.
Measurements will be obtained during inspiration and expiration, and the collapsibility index will be calculated as [(IVC diameter during expiration - IVC diameter during inspiration) / IVC diameter during expiration] × 100%.
Measurements will be performed preoperatively and 30 minutes after spinal anesthesia induction.
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Pre-anesthesia measurement.
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Flow-Mediated Dilation (FMD)
Time Frame: Pre-anesthesia measurement.
|
FMD will be measured using high-resolution ultrasound to assess endothelial function.
Measurements will be performed on the brachial artery at baseline and after inducing hyperemia with a blood pressure cuff.
FMD will be calculated as [(post-hyperemia diameter - baseline diameter) / baseline diameter] × 100%.
The average of three repeated measurements will be recorded for analysis.
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Pre-anesthesia measurement.
|
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Carotid Corrected Flow Time (CFTc)
Time Frame: Pre-anesthesia measurement.
|
Carotid Corrected Flow Time (CFTc) will be measured using Doppler ultrasound at the common carotid artery.
The uncorrected carotid flow time will be adjusted for heart rate using Bazett's formula (CFTc = observed flow time / √(R-R interval)).
Measurements will be taken preoperatively and at 30 minutes after spinal anesthesia induction.
The average of three consecutive measurements will be recorded.
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Pre-anesthesia measurement.
|
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
- 3.05.2024-27769
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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