Menu
Not yet recruiting NCT07496788

Investigation of the Role of Internal Jugular Vein Collapsibility Index in Predicting Spinal Anesthesia-Induced Hypotension in Preeclamptic Parturients

— Observational Spinal Anesthesia-Induced Hypotension Preeclampsia Cesarean Section

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Internal Jugular Vein Collapsibility Index Measurement.
Who it may be relevant to
Registry conditions: Spinal Anesthesia-Induced Hypotension, Preeclampsia, Cesarean Section. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This prospective, single-center observational study aims to evaluate the predictive value of the internal jugular vein collapsibility index (IJVCI) for spinal anesthesia-associated hypotension in preeclamptic parturients (gestational age ≥28 weeks) undergoing cesarean delivery classified as Lucas category 3-4. Preoperative IJVCI will be measured using ultrasonography before spinal anesthesia during spontaneous and deep respiration. The incidence of hypotension within the first 20 minutes after spinal anesthesia will be recorded. The diagnostic performance of IJVCI in predicting hypotension will be analyzed.

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.

Interventions

  • Other Internal Jugular Vein Collapsibility Index Measurement
    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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT07496788 · TABED 1-25-1325

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗