Preoperative Shock Indexes and Post-Spinal Hypotension in Cesarean Surgery
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spinal Anesthesia, Pregnancy, Hypotension Postprocedural. Basic parameters: from 18 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 →
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Official title
Predictive Performance of Preoperative Shock Index and Modified Shock Index for Hypotension Following Spinal Anesthesia in Elective Cesarean Surgery
Overview
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.
Primary outcome measures
- Predictive performances of preoperative shock indexes for intraoperative hypotension [Time frame: From induction of spinal anesthesia until end of surgery]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Patients over 18 years old
- ASA II-III patients undergoing elective cesarean section
Exclusion criteria
- 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
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
- Marmara University School of Medicine — Istanbul
Identifiers
NCT: NCT07500519 · 09.2025.25-0289