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Preoperative Shock Indexes and Post-Spinal Hypotension in Cesarean Surgery

ConditionsSpinal AnesthesiaPregnancyHypotension Postprocedural
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years old

ASA II-III patients undergoing elective cesarean section

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Postspinal hypotension
Group B: Post spinal non-hypotension

Trial outcomes

Primary outcomes

1

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.

Time frame
From induction of spinal anesthesia until end of surgery

Secondary outcomes

1

Incidence of intraoperative hypotension

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

Time frame
From induction of spinal anesthesia until end of surgery (intraoperative period)
2

Requirement for vasopressor treatment (ephedrine)

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

Time frame
From induction of spinal anesthesia until end of surgery
3

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.

Time frame
Intraoperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marmara University

Lead sponsor

Source ClinicalTrials.gov
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