Spinal Anesthesia-Induced HypotensionNCT07496788
Investigation of the Role of Internal Jugular Vein Collapsibility Index in Predicting Spinal Anesthesia-Induced Hypotension in Preeclamptic Parturients
An observational study of Spinal Anesthesia-Induced Hypotension and Preeclampsia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Spinal Anesthesia-Induced Hypotension, Preeclampsia, Cesarean Section
- What is being tested?
- Internal Jugular Vein Collapsibility Index Measurement
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 25 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women diagnosed with preeclampsia who are scheduled for cesarean delivery under spinal anesthesia at Ankara Bilkent City Hospital, with cesarean urgency classified as Lucas category 3-4. Eligible participants are aged 18-45 years, have ASA physical status II-III, and have a gestational age ≥28 weeks. Participants will be evaluated for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia..
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
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.
Read the 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.
- Being tested
- Internal Jugular Vein Collapsibility Index Measurement
- Keywords
- Preeclampsia, Spinal Anesthesia, Hypotension, Internal Jugular Vein, Collapsibility Index, Cesarean Section, Ultrasonography, Hemodynamic Monitoring
- Medical subject headings
- Pre-Eclampsia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Jugular Vein Collapsibility Index MeasurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Internal Jugular Vein Collapsibility Index Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Internal Jugular Vein Collapsibility Index for Spinal Anesthesia-Induced Hypotension
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.
Measured: From spinal anesthesia administration to 20 minutes post-spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion25 Jul 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Anesthesia-Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Aydin Guzey, Ankara City Hospital Bilkent
- Investigators
- Nihan Aydin Guzey, MD, PhD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496788
- Sponsor's protocol ID
- TABED 1-25-1325
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of Internal Jugular Vein Collapsibility Index in Predicting Spinal Anesthesia-Induced Hypotension in Preeclamptic Parturients
- ClinicalTrials.gov ID
- NCT07496788
- Acronym / sponsor ID
- TABED 1-25-1325
- Keywords
- Preeclampsia, Spinal Anesthesia, Hypotension, Internal Jugular Vein, Collapsibility Index, Cesarean Section, Ultrasonography, Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preeclamptic Parturients Undergoing Cesarean Section | – | Other: Internal Jugular Vein Collapsibility Index MeasurementPreeclamptic 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with preeclampsia who are scheduled for cesarean delivery under spinal anesthesia at Ankara Bilkent City Hospital, with cesarean urgency classified as Lucas category 3-4. Eligible participants are aged 18-45 years, have ASA physical status II-III, and have a gestational age ≥28 weeks. Participants will be evaluated for the development of spinal anesthesia-associated hypotension within the first 20 minutes after spinal anesthesia..
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Cesarean urgency classified as Lucas category 1-2
- Gestational age <28 weeks
- ASA physical status ≥ IV
- Known renal disease
- Cardiac instability or known arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Jugular Vein Collapsibility Index MeasurementPreoperative 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. | Other | Preeclamptic Parturients Undergoing Cesarean Section |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nihan Aydin Guzey, MD, PhD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia-Induced Hypotension and Preeclampsia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nihan Aydin Guzey, MD, PhD (+905056496231, nihanaydinguzey@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.