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Comparison of the Inflammatory Response in Patients Undergoing Surgery for Degenerative Spinal Diseases: Sevoflurane-Based Balanced Anesthesia Versus Target-Controlled Propofol Infusion (TCI)

8 de noviembre de 2026 actualizado por: Mateo Peric, University Clinical Hospital Mostar

Comparison of the Inflammatory Response of the Organism After Surgical Treatment of Degenerative Spina Diseases Under Balanced Anesthesia and Target Controlled Infusion Anesthesia

A prospective cohort study with patients undergoing surgery at the Neurosurgery Clinic of the University Clinical Hospital Mostar.

Inclusion/Exclusion Criteria: Inclusion criteria will be: a) patients over 18 years of age undergoing elective surgery for degenerative spine diseases b) ASA status 1-3 Exclusion criteria will be: a) emergency surgeries b) spinal trauma c) allergy to any of the drugs routinely administered during surgery (cefazolin, pantoprazole, metoclopramide, sevoflurane, propofol, fentanyl) d) patients under 18 years of age e) ASA status 4 Variables and Data Sources: General patient data will be collected (gender, age, height, weight), comorbidities, and baseline values for hemoglobin, hematocrit, leukocytes, C-reactive protein (CRP), interleukin 6 (IL-6), ferritin, blood glucose (BG), creatine kinase, myoglobin, and cholesterol. These values will be monitored on the first and second postoperative days, and the dynamics of the results will be recorded. Intraoperatively, the need for vasopressors and transfusions will be documented, and the occurrence of postoperative infections, as well as postoperative nausea and vomiting, will be monitored.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

Patients undergoing surgical treatment for degenerative spinal disease will be randomly assigned to two groups.

The first group will receive balanced anesthesia. Anesthesia will be induced using propofol, fentanyl, and a neuromuscular blocking agent, most commonly atracurium, while hypnosis will be maintained using an inhaled mixture of sevoflurane, oxygen, and air.

The second group will receive total intravenous anesthesia (TIVA). Anesthesia will be induced in the same manner as in the first group, while hypnosis during surgery will be maintained by a continuous infusion of propofol, adjusted according to the target plasma concentration of propofol (target-controlled infusion anesthesia - TCI anesthesia), with an oxygen-air mixture.

All patients will have their comorbidities documented, with particular emphasis on obesity, arterial hypertension, hypercholesterolemia, and diabetes mellitus. Their American Society of Anesthesiologists (ASA) physical status classification will also be recorded.

Patients' sex, body weight, and height will be recorded, and their body mass index (BMI) will be calculated.

Before transfer to the operating room, all participants will receive premedication with midazolam at a dose of 0.02-0.04 mg/kg. Antibiotic prophylaxis with a first-generation cephalosporin will be administered and repeated every three hours.

Preoperative baseline levels of hemoglobin, hematocrit, leukocytes, C-reactive protein (CRP), interleukin-6 (IL-6), ferritin, blood glucose, creatine kinase (CK), myoglobin, and cholesterol will be measured. The same laboratory parameters will be assessed on the first and second postoperative days, and changes in their values over time will be recorded. Intraoperative blood glucose levels will also be monitored.

The need for blood product transfusion will be documented.

The depth of anesthesia will be monitored intraoperatively using entropy monitoring, and anesthetic doses will be adjusted to maintain entropy values between 40 and 60.

An arterial catheter will be inserted in all patients for invasive arterial blood pressure monitoring. Blood pressure will be maintained within 30% of the initial recorded value. Hypotension will be treated with ephedrine and/or norepinephrine. The administration of these medications will be documented and compared between the two groups.

Normal saline and other balanced crystalloid solutions will be used for intraoperative fluid replacement.

Before the end of surgery, all patients will receive analgesics for postoperative pain management. Antiemetic medications will also be administered, and the incidence of postoperative nausea and vomiting will be recorded.

Pain levels will be assessed before and after surgery. The duration of anesthesia will be documented. Pain intensity will be measured using the Visual Analog Scale (VAS).

The incidence of postoperative surgical site infections will also be monitored.

**Exclusion criteria** will include patients under 18 years of age, emergency surgical procedures, surgery for malignant diseases, and patients with contraindications to cephalosporins or any of the anesthetic agents used in the study.

The planned duration of the study is one to two years.

All surgical procedures will be performed in the neurosurgical operating room of the University Clinical Hospital Mostar. Intraoperative computed tomography (CT) with navigation will be used to ensure more precise placement of spinal implants.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • Fase 4

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

Ubicaciones de estudio

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • patients over 18 years of age undergoing elective surgery for degenerative spine diseases
  • ASA status 1-3

Exclusion Criteria:

  • emergency surgeries
  • spinal trauma
  • allergy to any of the drugs routinely administered during surgery (cefazolin, pantoprazole, metoclopramide, sevoflurane, propofol, fentanyl)
  • patients under 18 years of age
  • ASA status 4
  • patients with imunosupressive therapy

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Sevoflurane-Based Balanced Anesthesia

Patients undergoing surgery for degenerative spinal diseases will receive balanced general anesthesia maintained with sevoflurane. The perioperative inflammatory response will be assessed using inflammatory biomarkers.

General anesthesia maintained with inhaled sevoflurane as part of a balanced anesthesia technique during surgery for degenerative spinal diseases.

Experimental: Propofol-Based Total Intravenous Anesthesia (TCI)

Patients undergoing surgery for degenerative spinal diseases will receive total intravenous anesthesia maintained with propofol administered using target-controlled infusion (TCI). The perioperative inflammatory response will be assessed using inflammatory biomarkers.

General anesthesia maintained with intravenous propofol administered using target-controlled infusion (TCI) during surgery for degenerative spinal diseases.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Serum Interleukin-6 (IL-6) Concentration
Periodo de tiempo: Before anesthesia induction (baseline), 4 hours and 24 hours after completion of surgery.

Change in serum IL-6 concentration from baseline will be compared between patients receiving sevoflurane-based balanced anesthesia and propofol-based total intravenous anesthesia (TCI). IL-6 concentrations will be measured using an ELISA assay.

Before anesthesia induction (baseline), 4 hours and 24 hours after completion of surgery.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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