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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From induction of spinal anesthesia until end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative hypotension | Proportion of patients meeting the predefined hypotension criteria during the intraoperative period. | From induction of spinal anesthesia until end of surgery (intraoperative period) |
| Requirement for vasopressor treatment (ephedrine) |
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Inclusion Criteria:
Exclusion Criteria:
Female participants only (pregnant women undergoing elective cesarean surgery)
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The study population will consist of pregnant women undergoing elective cesarean surgery under spinal anesthesia at Marmara University School of Medicine, Department of Anesthesiology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beliz Bilgili | Contact | +905362187927 | belizbilgili@gmail.com | |
| Beyza Betül Özkurt | Contact | +905302992210 | beyzaozkurt@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara University School of Medicine | Recruiting | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Proportion of patients who receive any vasopressor for hypotension and total number treated. |
| 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. | Intraoperative period |