Diastolic Shock Index for Predicting Postspinal Hypotension
August 11, 2026 updated by: İlke Dolgun, Istinye University
Comparison of the Diagnostic Performance of the Diastolic Shock Index and Other Shock Indices in Predicting Postspinal Hypotension
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This prospective observational study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia.
The study aims to evaluate the performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare it with the Shock Index, Modified Shock Index, and Age Shock Index.
Baseline systolic, diastolic, and mean arterial pressures and heart rate will be recorded before spinal anesthesia and used to calculate the four shock indices.
Hemodynamic parameters will also be recorded at 5, 10, 15, and 20 minutes after spinal anesthesia as part of routine clinical monitoring, without any additional intervention for research purposes.Postspinal hypotension will be defined as a decrease in systolic arterial pressure of at least 25% from baseline and/or a systolic arterial pressure below 90 mmHg.
The primary outcome will be postspinal hypotension, while secondary outcomes will include ephedrine requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated indices.
Receiver operating characteristic curve analysis will be used to compare the indices and determine the optimal cut-off value for the Diastolic Shock Index, with a minimum of 85 patients planned for inclusion.
Study Type
Observational
Enrollment (Estimated)
85
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ilke dolğun
- Phone Number: 5555485632
- Email: ilkeser2004@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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.
Description
Inclusion Criteria:
- 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
- Provision of written informed consent
Exclusion Criteria:
- Refusal to participate in the study
- Emergency surgery
- Bilateral inguinal hernia surgery
- Contraindication to spinal anesthesia
- Failure of spinal anesthesia or conversion to general anesthesia due to failed spinal block
- Requirement for additional general anesthesia or deep sedation during surgery
- Operation duration exceeding 120 minutes
- Atrial fibrillation, atrial flutter, frequent ventricular ectopy, or other arrhythmias preventing reliable heart rate assessment
- Presence of a permanent cardiac pacemaker
- Severe valvular heart disease
- New York Heart Association class III-IV heart failure
- Preoperative use of vasopressor or inotropic therapy
- Severe hepatic failure or end-stage renal disease
- Neurological disease that may significantly affect autonomic nervous system function
- Preoperative hemodynamic instability, defined as systolic arterial pressure <90 mmHg or >180 mmHg, or heart rate <50 or >120 beats/min
- Missing study data or inability to obtain records in accordance with the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients Who Develop Postspinal Hypotension
Patients who develop 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.
|
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.
|
|
Patients Who Do Not Develop Postspinal Hypotension
Patients who do not develop postspinal hypotension, defined as the absence of a decrease in systolic arterial pressure of 25% or more from baseline and a systolic arterial pressure remaining at or above 90 mmHg following spinal anesthesia.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of Postspinal Hypotension
Time Frame: Within the first 20 minutes after spinal anesthesia
|
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.
|
Within the first 20 minutes after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
- Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
- Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vasquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 21, 2026
Primary Completion (Estimated)
February 21, 2027
Study Completion (Estimated)
March 7, 2027
Study Registration Dates
First Submitted
August 11, 2026
First Submitted That Met QC Criteria
August 11, 2026
First Posted (Actual)
August 14, 2026
Study Record Updates
Last Update Posted (Actual)
August 14, 2026
Last Update Submitted That Met QC Criteria
August 11, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- şilan tez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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