Spinal AnesthesiaNCT07500519
Preoperative Shock Indexes and Post-Spinal Hypotension in Cesarean Surgery
An observational study of Spinal Anesthesia and Pregnancy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Anesthesia, Pregnancy, Hypotension Postprocedural
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 30 Aug 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of pregnant women undergoing elective cesarean surgery under spinal anesthesia at Marmara University School of Medicine, Department of Anesthesiology.
Who may be able to join
- Patients over 18 years old
- ASA II-III patients undergoing elective cesarean section
Who cannot join
- ASA IV patients
- Patients with known neurologic or psychiatric disorders
- Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
- Patients with alcohol or drug addiction
- Mentally disabled patients
- Patients with BMI>30
- Patients who develop massive bleeding or coagulopathy
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, 1 recruiting
- Recruiting
Marmara University School of Medicine
Istanbul
Beliz Biilgili, Prof dr, 00905362187927, belizbilgili@gmail.com
About this study
Official title: Predictive Performance of Preoperative Shock Index and Modified Shock Index for Hypotension Following Spinal Anesthesia in Elective Cesarean Surgery
This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management.
Read the detailed description
This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management.
Eligible pregnant women scheduled for elective cesarean surgery under spinal anesthesia will be assessed preoperatively for SI and MSI. Blood pressure and hemodynamic parameters will be monitored throughout the perioperative period to identify the occurrence and severity of hypotension. The study will analyze the ability of SI and MSI to predict hypotensive events and determine optimal cutoff values for clinical use.
The findings of this study may provide evidence to improve perioperative risk stratification, guide preventive interventions, and enhance maternal and fetal safety during elective cesarean surgery.
- Conditions
- Spinal Anesthesia, Pregnancy, Hypotension Postprocedural
- Keywords
- Hypotension, Cesarean Section, Spinal Anesthesia, Shock Index
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postspinal hypotension | All patients undergoing elective cesarean surgery under spinal anesthesia will be included in this study. Preoperative Shock Index (SI) and Modified Shock Index (MSI) will be calculated prior to anesthesia. Patients will be monitored during the surgery for hypotension. The patients who experience hypotension will be recorded as the post spinal hypotension group. The predictive performance of SI and MSI for post-spinal hypotension will be analyzed. | |
| Post spinal non-hypotension | All patients undergoing elective cesarean surgery under spinal anesthesia will be included in this study. Preoperative Shock Index (SI) and Modified Shock Index (MSI) will be calculated prior to anesthesia. Patients will be monitored during the surgery for hypotension. The patients who do not experience hypotension will be recorded as the post spinal non-hypotension group. The predictive performance of SI and MSI for post-spinal hypotension will be analyzed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performances of preoperative shock indexes for intraoperative hypotension
The ability of preoperative SI and MSI to predict intraoperative hypotension will be evaluated using receiver operating characteristic (ROC) analysis; area under the curve (AUC), sensitivity, specificity, and optimal cutoff values will be reported. SI is calculated as heart rate ÷ systolic blood pressure (HR/SBP); MSI is calculated as heart rate ÷ mean arterial pressure (HR/MAP). Hypotension is defined as a decrease of SBP to <80% of baseline or SBP <100 mmHg, or MAP <80% of baseline or MAP <65 mmHg.
Measured: From induction of spinal anesthesia until end of surgery
Secondary outcomes (3)
Incidence of intraoperative hypotension
Proportion of patients meeting the predefined hypotension criteria during the intraoperative period.
Measured: From induction of spinal anesthesia until end of surgery (intraoperative period)
Requirement for vasopressor treatment (ephedrine)
Proportion of patients who receive any vasopressor for hypotension and total number treated.
Measured: From induction of spinal anesthesia until end of surgery
Classification into hypotension vs. no-hypotension groups for comparison analyses
Number and proportion of patients classified as having developed hypotension vs not; used for subgroup analyses of baseline SI/MSI and outcomes.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Oct 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500519
- Sponsor's protocol ID
- 09.2025.25-0289
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Performance of Preoperative Shock Index and Modified Shock Index for Hypotension Following Spinal Anesthesia in Elective Cesarean Surgery
- ClinicalTrials.gov ID
- NCT07500519
- Acronym / sponsor ID
- 09.2025.25-0289
- Conditions
- Spinal Anesthesia, Pregnancy, Hypotension Postprocedural
- Keywords
- Hypotension, Cesarean Section, Spinal Anesthesia, Shock Index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 30 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 observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management.
Detailed description
This prospective observational study aims to evaluate the predictive performance of preoperative Shock Index (SI) and Modified Shock Index (MSI) for hypotension following spinal anesthesia in elective cesarean surgery. Post-spinal hypotension is a common complication that can affect maternal and fetal outcomes, and early identification of at-risk patients is essential for effective perioperative management.
Eligible pregnant women scheduled for elective cesarean surgery under spinal anesthesia will be assessed preoperatively for SI and MSI. Blood pressure and hemodynamic parameters will be monitored throughout the perioperative period to identify the occurrence and severity of hypotension. The study will analyze the ability of SI and MSI to predict hypotensive events and determine optimal cutoff values for clinical use.
The findings of this study may provide evidence to improve perioperative risk stratification, guide preventive interventions, and enhance maternal and fetal safety during elective cesarean surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postspinal hypotension | – | –All patients undergoing elective cesarean surgery under spinal anesthesia will be included in this study. Preoperative Shock Index (SI) and Modified Shock Index (MSI) will be calculated prior to anesthesia. Patients will be monitored during the surgery for hypotension. The patients who experience hypotension will be recorded as the post spinal hypotension group. The predictive performance of SI and MSI for post-spinal hypotension will be analyzed. |
| Post spinal non-hypotension | – | –All patients undergoing elective cesarean surgery under spinal anesthesia will be included in this study. Preoperative Shock Index (SI) and Modified Shock Index (MSI) will be calculated prior to anesthesia. Patients will be monitored during the surgery for hypotension. The patients who do not experience hypotension will be recorded as the post spinal non-hypotension group. The predictive performance of SI and MSI for post-spinal hypotension will be analyzed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of pregnant women undergoing elective cesarean surgery under spinal anesthesia at Marmara University School of Medicine, Department of Anesthesiology.
Key inclusion criteria (2 listed)
- Patients over 18 years old
- ASA II-III patients undergoing elective cesarean section
Key exclusion criteria (7 listed)
- ASA IV patients
- Patients with known neurologic or psychiatric disorders
- Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
- Patients with alcohol or drug addiction
- Mentally disabled patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive performances of preoperative shock indexes for intraoperative hypotension
Time frame: From induction of spinal anesthesia until end of surgery
The ability of preoperative SI and MSI to predict intraoperative hypotension will be evaluated using receiver operating characteristic (ROC) analysis; area under the curve (AUC), sensitivity, specificity, and optimal cutoff values will be reported. SI is calculated as heart rate ÷ systolic blood pressure (HR/SBP); MSI is calculated as heart rate ÷ mean arterial pressure (HR/MAP). Hypotension is defined as a decrease of SBP to <80% of baseline or SBP <100 mmHg, or MAP <80% of baseline or MAP <65 mmHg.
3 secondary outcomes
Incidence of intraoperative hypotension
Time frame: From induction of spinal anesthesia until end of surgery (intraoperative period)
Requirement for vasopressor treatment (ephedrine)
Time frame: From induction of spinal anesthesia until end of surgery
Classification into hypotension vs. no-hypotension groups for comparison analyses
Time frame: Intraoperative period
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 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 and Pregnancy, run by Marmara University 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 2 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: looking for participants now, as of the sponsor's last update on 30 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 Beliz Bilgili (+905362187927, belizbilgili@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive performances of preoperative shock indexes for intraoperative hypotension (time frame: From induction of spinal anesthesia until end of surgery). 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 30 Mar 2026.