- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496788
Investigation of the Role of Internal Jugular Vein Collapsibility Index in Predicting Spinal Anesthesia-Induced Hypotension in Preeclamptic Parturients
Study Overview
Status
Intervention / Treatment
Detailed Description
This prospective, single-center observational study is designed to evaluate the predictive value of the internal jugular vein collapsibility index (IJVCI) for spinal anesthesia-associated hypotension in preeclamptic parturients undergoing cesarean delivery classified as Lucas category 3-4.
Eligible patients aged 18-45 years with ASA physical status II-III and singleton pregnancies at ≥28 weeks of gestation will be enrolled. Preoperative ultrasonographic measurements of the right internal jugular vein will be performed to calculate IJVCI using M-mode imaging. Maximum and minimum diameters during spontaneous and deep respiration will be recorded.
Spinal anesthesia will be performed with hyperbaric bupivacaine. Hemodynamic parameters (systolic, diastolic and mean arterial pressure, heart rate, and oxygen saturation) will be monitored with blood pressure measurements every 2 minutes during the first 20 minutes and then every 5 minutes thereafter. Hypotension will be defined as a ≥30% decrease in mean arterial pressure from baseline or systolic blood pressure <100 mmHg. Hypotension will be treated according to the study protocol with ephedrine boluses as needed.
The primary outcome is the incidence of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia. Secondary outcomes include total ephedrine consumption, number and duration of hypotensive episodes, estimated blood loss, and neonatal outcomes (Apgar scores). The diagnostic performance of IJVCI will be evaluated using receiver operating characteristic (ROC) curve analysis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nihan Aydin Guzey, MD, PhD
- Phone Number: +905056496231
- Email: nihanaydinguzey@gmail.com
Study Contact Backup
- Name: Basak Mizrak Demirbuken, MD
- Phone Number: +90509464248
- Email: basakmizrak@gmail.com
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 45 years
- ASA physical status II-III
- Diagnosed with preeclampsia
- Scheduled for cesarean delivery under spinal anesthesia with cesarean urgency classified as Lucas category 3-4
- Gestational age ≥28 weeks
- Provided written informed consent
Exclusion Criteria:
- Cesarean urgency classified as Lucas category 1-2
- Gestational age <28 weeks
- ASA physical status ≥ IV
- Known renal disease
- Cardiac instability or known arrhythmia
- Requirement of general anesthesia or sedation
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Preeclamptic Parturients Undergoing Cesarean Section
Preeclamptic pregnant women aged 18-45 years with ASA physical status II-III and gestational age ≥28 weeks who are scheduled for cesarean delivery under spinal anesthesia, with cesarean urgency classified as Lucas category 3-4.
Preoperative internal jugular vein collapsibility index (IJVCI) will be measured using ultrasonography before spinal anesthesia, and participants will be followed for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia.
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Preoperative ultrasonographic measurement of the internal jugular vein collapsibility index (IJVCI) performed before spinal anesthesia in preeclamptic parturients (gestational age ≥28 weeks) undergoing cesarean delivery classified as Lucas category 3-4.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Value of Internal Jugular Vein Collapsibility Index for Spinal Anesthesia-Induced Hypotension
Time Frame: From spinal anesthesia administration to 20 minutes post-spinal anesthesia
|
Diagnostic performance of the preoperative internal jugular vein collapsibility index (IJVCI) for predicting spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia, assessed by receiver operating characteristic (ROC) curve analysis.
Hypotension will be defined as a ≥30% decrease in mean arterial pressure from baseline or systolic blood pressure <100 mmHg.
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From spinal anesthesia administration to 20 minutes post-spinal anesthesia
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nihan Aydin Guzey, MD, PhD, Ankara City Hospital Bilkent
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TABED 1-25-1325
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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