Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07500519

Preoperative Shock Indexes and Post-Spinal Hypotension in 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Spinal Anesthesia Cardiovascular Diseases Hypotension Hypotension Postprocedural Pregnancy Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Beliz Biilgili, Prof dr

CONTACT

[email protected]

00905362187927

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of intraoperative hypotension

    Time frame: From induction of spinal anesthesia until end of surgery (intraoperative period)

    Proportion of patients meeting the predefined hypotension criteria during the intraoperative period.

  2. Requirement for vasopressor treatment (ephedrine)

    Time frame: From induction of spinal anesthesia until end of surgery

    Proportion of patients who receive any vasopressor for hypotension and total number treated.

  3. Classification into hypotension vs. no-hypotension groups for comparison analyses

    Time frame: Intraoperative period

    Number and proportion of patients classified as having developed hypotension vs not; used for subgroup analyses of baseline SI/MSI and outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Beliz Bilgili

CONTACT

[email protected]

+905362187927

Beyza Betül Özkurt

CONTACT

[email protected]

+905302992210

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Predictive Performance of Preoperative Shock Index and Modified Shock Index for Hypotension Following Spinal Anesthesia in Elective Cesarean Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.