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Effect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery

2 de septiembre de 2026 actualizado por: Ain Shams University
The aim of this study is to detect the effect of intraoperative intravenous magnesium sulfate on postoperative systemic inflammatory response by serum inflammatory parameters as CRP, WBCS and neutrophil count.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The aim of this study is to detect the effect of intraoperative intravenous magnesium sulfate on postoperative systemic inflammatory response by serum inflammatory parameters as CRP, WBCS and neutrophil count. In the anesthesia clinic, an informed written consent will be taken from every patient one day before the surgery. Anesthesia will be provided according to the hospital protocol in respect to preoperative investigations, fasting hours and intra-operative monitoring and drugs. VAS score will be explained to the patient and how to express pain intensity with the use of Visual Analogue Scale (VAS); 10 cm unmarked line in which 0=no pain, 10 cm= the worst imaginable pain. All patients will be clinically assessed and standard preoperative investigations will be done; Complete Blood Count, Coagulation profile, liver function tests, kidney function tests, CRP, chest x-ray and ECG. Intraoperative monitoring items included non-invasive blood pressure (NIBP), heart rate (HR), electrocardiography (ECG), pulse oximetry (Spo2), end-tidal CO2 (EtCo2) and urine output (UOP). Pre-induction hemodynamic parameters (heart rate and mean arterial pressure) will be recorded. General anesthesia will be encouraged with propofol (2 mg/kg) IV followed by atracurium 0.5 mg/kg IV and fentanyl 1 ug/kg. After 3 minutes, intubation will be done. Anesthesia will be maintained with isoflurane 1% MAC in oxygen, air and atracurium 0.1 mg/kg. After the induction of anesthesia, For the patients in group A (study group) (26 patients), a bolus dose of magnesium sulfate (50 mg/Kg over 20 minutes) will be administered then, the maintenance dose of magnesium sulfate (15mg/Kg/hour) will be infused till the end of the surgery. In group B (control group) (26 patients), the patients will receive normal saline with the same volume and the same infusion model. The study drug (MgSO4) and the placebo (normal saline) will be prepared in the hospital pharmacy. Each one will be assigned a code so that the anesthetist will remain blinded to group allocation. Intravenous fentanyl infusion 0.4µg/kg/hr will be administrated during intraoperative period till the end of surgery. At the end of surgery, inhalational anesthetics will be discontinued and muscle relaxant will be reversed by intravenous atropine 10 μg/kg and neostigmine 0.05 mg/kg. In both groups, hemodynamic parameters as heart rate and mean blood pressure (MAP) will be continuously monitored till the end of surgery in addition that urine output (UOP) will be frequently monitored and recorded. If heart rate becomes less than 50 bpm, 0.5 mg IV atropine will be given. 10 mg IV ephedrine will be given if mean arterial pressure becomes less than 60 mmHg. Time of recovery (time period from stopping the anesthetic drug administration and the surgical process has been completed to extubation) will be measured in each group.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

52

Fase

  • No aplica

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

Copia de seguridad de contactos de estudio

  • Nombre: Sherif Farouq Ibrahim El Shantory, Professor
  • Número de teléfono: +20199811994

Ubicaciones de estudio

    • Abbassia
      • Cairo, Abbassia, Egipto, 00202
        • Reclutamiento
        • Ain Shams University
        • Contacto:
        • Contacto:
          • Sherif Farouq Ibrahim El Shantory, Professor
          • Número de teléfono: +201099811994
          • Correo electrónico: nadaelaidy1995@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

Descripción

Inclusion Criteria:

  • ASA I and ASA II.
  • Age (35yrs - 75yrs).
  • Patients undergoing open colorectal cancer surgery.
  • Sex: Both sexes.

Exclusion Criteria:

  • Renal impairment (Glomerular Filtration Rate < 60 ml\min).
  • Severe cardiac dysfunction (Ejection fraction ≤ 30% or clinical signs and symptoms of reduced left ventricular ejection fraction), preoperative bradycardia (HR < 50 bpm) and atrioventricular block (first, second and third degree).
  • Allergy to study drug (MgSO4).
  • Patient refusal to precipitate in this study.
  • Autoimmune disorders (eg: rheumatoid arthritis, multiple sclerosis and lupus), congenital and acquired immunodeficiency.
  • Previous / current immunomodulatory therapy.
  • Emergency condition (eg: obstruction or perforation in colorectal cancer).
  • Postoperative complications altering inflammatory response (eg: infection, anastomotic leak).
  • Duration of operation > 5 hours.
  • Cognitive impairment (eg: Dementia) and other psychiatric disorders by history.
  • Body mass index less than 18 or greater than 30 kg/m².

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: study group (magnesium sulfate group)
After the induction of anesthesia, the patients will receive loading intravenous magnesium sulfate (50mg/kg over 20 minutes) and maintenance (15mg/kg/hr) till the end of surgery.
After the induction of anesthesia, the patients will receive loading intravenous magnesium sulfate (50mg/kg over 20 minutes) and maintenance (15mg/kg/hr) till the end of surgery.
Comparador de placebos: control group
The patients will receive the same normal saline volume for loading and maintenance.
The patients will receive the same normal saline volume for loading and maintenance.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
postoperative white blood cell count (WBC)
Periodo de tiempo: inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.
Assess effect of intravenous magnesium sulfate on postoperative inflammation by serum inflammatory marker as WBCS.
inflammatory markers will be measured at 2 time points: 12 and 36 hours after surgery.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
postoperative C-reactive protein (CPR)
Periodo de tiempo: during 36 hrs postoperative.CRP will be measured at 2 time points: 12 and 36 hours after surgery.
Effect of intravenous magnesium sulfate on postoperative serum C-reactive protein level.
during 36 hrs postoperative.CRP will be measured at 2 time points: 12 and 36 hours after surgery.
postoperative neutrophil count
Periodo de tiempo: 12 and 36 hours after surgery.
Effect of intravenous magnesium sulfate on postoperative neutrophil count.
12 and 36 hours after surgery.
Time to recovery from anesthesia
Periodo de tiempo: immediately after surgery
time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation.
immediately after surgery
Postoperative pain intensity
Periodo de tiempo: During the first 36 hours postoperatively.
Postoperative pain intensity assessed using the visual Analog Scale (VAS).
During the first 36 hours postoperatively.
Time to first postoperative analgesic requirement
Periodo de tiempo: During the first 36 hours postoperatively.
Time from extubation to the first postoperative administration of rescue analgesia.
During the first 36 hours postoperatively.
Cumulative postoperative nalbuphine consumption
Periodo de tiempo: During the first 36 hours postoperatively.
total dose of nalbuphine administered to each patient as postoperative rescue analgesia for 36h.
During the first 36 hours postoperatively.
Postoperative side effects as nausea, vomiting, bradycardia and hypotension
Periodo de tiempo: During the first 36 hours postoperatively.
incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension.
During the first 36 hours postoperatively.

Colaboradores e Investigadores

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

Patrocinador

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 (Actual)

1 de marzo de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

27 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de septiembre de 2026

Publicado por primera vez (Actual)

3 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

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

2 de septiembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • FMASU MD 30/2026

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. .