Diastolic Shock Index for Predicting Postspinal Hypotension

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorIstinye University

About this trial

This prospective observational study aims to evaluate the diagnostic performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare its performance with other shock indices, including the Shock Index, Modified Shock Index, and Age Shock Index. The study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia. Hemodynamic parameters will be recorded before and after spinal anesthesia as part of routine clinical monitoring. The primary outcome is the development of postspinal hypotension. Secondary outcomes include vasopressor requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated shock indices using receiver operating characteristic curve analysis. No additional intervention beyond routine anesthetic and perioperative care will be performed for study purposes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50 years or older

Scheduled for elective unilateral inguinal hernia surgery

Scheduled to undergo surgery under spinal anesthesia

American Society of Anesthesiologists physical status I-III

Disqualifiers

Refusal to participate in the study

Emergency surgery

Bilateral inguinal hernia surgery

Contraindication to spinal anesthesia

Trial population

The study population will consist of patients aged 50 years and older who are scheduled to undergo elective unilateral inguinal hernia surgery under spinal anesthesia at the University of Health Sciences Haseki Training and Research Hospital. Eligible patients with American Society of Anesthesiologists physical status I-III who provide written informed consent will be included. A minimum of 85 patients is planned for enrollment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Spinal Anesthesia

    Procedure/Surgery

    Spinal anesthesia will be administered as part of routine clinical care for elective unilateral inguinal hernia surgery. The study will not modify the anesthetic management or introduce any additional intervention for research purposes. Hemodynamic parameters obtained during routine perioperative monitoring will be recorded to evaluate the development of postspinal hypotension.

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Patients Who Develop Postspinal Hypotension1 intervention
Group B: Patients Who Do Not Develop Postspinal Hypotension1 intervention

Trial outcomes

Primary outcomes

1

Development of Postspinal Hypotension

Occurrence of postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.

Time frame
Within the first 20 minutes after spinal anesthesia

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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