- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07803601
Effect of Intravenous Magnesium on Postoperative Systemic Inflammatory Response in Patients Undergoing Colorectal Cancer Surgery
2 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
52
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Nada sami abdelfattah mohammed, M.Sc.
- Telefoonnummer: +201119256004 +201095640453
- E-mail: NadaSamiAbdelfattah@med.asu.edu.eg
Studie Contact Back-up
- Naam: Sherif Farouq Ibrahim El Shantory, Professor
- Telefoonnummer: +20199811994
Studie Locaties
-
-
Abbassia
-
Cairo, Abbassia, Egypte, 00202
- Werving
- Ain Shams University
-
Contact:
- Nada sami abdelfattah mohammed, M.Sc.
- Telefoonnummer: +201119256004 +201095640453
- E-mail: NadaSamiAbdelfattah@med.asu.edu.eg
-
Contact:
- Sherif Farouq Ibrahim El Shantory, Professor
- Telefoonnummer: +201099811994
- E-mail: nadaelaidy1995@gmail.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
|
Placebo-vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
postoperative white blood cell count (WBC)
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
postoperative C-reactive protein (CPR)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: immediately after surgery
|
time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation.
|
immediately after surgery
|
|
Postoperative pain intensity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: During the first 36 hours postoperatively.
|
incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension.
|
During the first 36 hours postoperatively.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2026
Primaire voltooiing (Geschat)
1 maart 2027
Studie voltooiing (Geschat)
1 april 2027
Studieregistratiedata
Eerst ingediend
27 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
2 september 2026
Eerst geplaatst (Werkelijk)
3 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 september 2026
Laatste update ingediend die voldeed aan QC-criteria
2 september 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Postoperatieve complicaties
- Pathologische processen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Pijn, postoperatief
- Zwavelverbindingen
- Farmaceutische voorbereidingen
- Anorganische chemicaliën
- Crystalloid -oplossingen
- Isotone oplossingen
- Oplossingen
- Zwavelzuren
- Sulfaten
- Zwavelzuren
- Magnesiumverbindingen
- Magnesiumsulfaat
- Zoutoplossing
Andere studie-ID-nummers
- FMASU MD 30/2026
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .