Ain shams university
Cairo, Abbassia, 00202, Egypt
Location status: Recruiting
Location contact
Nada sami abdelfattah mohammed, M.Sc.
CONTACT
+201095640453 ext. +201119256004
Sherif Farouq Ibrahim El Shantory, Professor
CONTACT
NCT Number: NCT07803601
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.
Interested in participating?
Request Info35 year–75 year
All sexes
Interventional
Not applicable
Cairo, Abbassia, 00202, Egypt
Location status: Recruiting
Nada sami abdelfattah mohammed, M.Sc.
CONTACT
+201095640453 ext. +201119256004
Sherif Farouq Ibrahim El Shantory, Professor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The patients will receive the same normal saline volume for loading and maintenance.
Time frame: 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.
Time frame: 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.
Time frame: 12 and 36 hours after surgery.
Effect of intravenous magnesium sulfate on postoperative neutrophil count.
Time frame: immediately after surgery
time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation.
Time frame: During the first 36 hours postoperatively.
Postoperative pain intensity assessed using the visual Analog Scale (VAS).
Time frame: During the first 36 hours postoperatively.
Time from extubation to the first postoperative administration of rescue analgesia.
Time frame: During the first 36 hours postoperatively.
total dose of nalbuphine administered to each patient as postoperative rescue analgesia for 36h.
Time frame: During the first 36 hours postoperatively.
incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension.
Contact information is provided by the study sponsor or research team.
Nada sami abdelfattah mohammed, M.Sc.
CONTACT
+201095640453 ext. +201119256004
Sherif Farouq Ibrahim El Shantory, Professor
CONTACT
Ain Shams University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07800364
Neurologic Manifestations, Pain
Tanta, Gharbia Governorate, Egypt
View Trial DetailsNCT07800403
Neurologic Manifestations, Pain
Minya, Egypt
View Trial DetailsNCT07571252
Neurologic Manifestations, Orthognathic Surgery
San Juan, Puerto Rico
View Trial DetailsNCT07788027
Neurologic Manifestations, Pain
Minya, Egypt
View Trial Details