Diastolic Shock Index for Predicting Postspinal Hypotension
11 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
85
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: ilke dolğun
- Número de teléfono: 5555485632
- Correo electrónico: ilkeser2004@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Development of Postspinal Hypotension
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
21 de agosto de 2026
Finalización primaria (Estimado)
21 de febrero de 2027
Finalización del estudio (Estimado)
7 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de agosto de 2026
Publicado por primera vez (Actual)
14 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- şilan tez
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
There is no plan to make individual participant data available to other researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .