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Preoperative Shock Indexes and Post-Spinal Hypotension in Cesarean Surgery

M

Marmara University

Status

Enrolling

Conditions

Spinal Anesthesia
Hypotension Postprocedural
Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT07500519
09.2025.25-0289

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Postspinal hypotension
Description:
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
Description:
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

Trial contacts and locations

1

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Central trial contact

Beliz Bilgili; Beyza Betül Özkurt

Data sourced from clinicaltrials.gov

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