Diastolic Shock Index for Predicting Postspinal Hypotension

NCT07765342 | Not Yet Recruiting

• 1 other identifier: şilan tez
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postspinal Hypotension

Outcome Measures

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.

  Within the first 20 minutes after spinal anesthesia

Study Arms (2)

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.

Procedure: Spinal Anesthesia

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.

Procedure: Spinal Anesthesia

Interventions

Spinal Anesthesia PROCEDURE

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 Develop Postspinal Hypotension; Patients Who Do Not Develop Postspinal Hypotension

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Related Publications (3)

• 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.

  PMID: 30236233 RESULT

• 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.

  PMID: 29189290 RESULT

• 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.

  PMID: 1599111 RESULT

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

ilke dolğun

CONTACT

5555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 21, 2026
• Primary Completion (Estimated): February 21, 2027
• Study Completion (Estimated): March 7, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share