Post Operative Inflammatory Marker Levels, Post Operative Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
DRUGNormal Saline
The patients will receive the same normal saline volume for loading and maintenance.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative white blood cell count (WBC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative C-reactive protein (CPR) | 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. |
| postoperative neutrophil count | 12 and 36 hours after surgery. | Effect of intravenous magnesium sulfate on postoperative neutrophil count. |
| Time to recovery from anesthesia | immediately after surgery | time from discontinuation of anesthetic drug administration and completion of the surgical procedure until extubation. |
| Postoperative pain intensity | During the first 36 hours postoperatively. | Postoperative pain intensity assessed using the visual Analog Scale (VAS). |
| Time to first postoperative analgesic requirement | During the first 36 hours postoperatively. | Time from extubation to the first postoperative administration of rescue analgesia. |
| Cumulative postoperative nalbuphine consumption | During the first 36 hours postoperatively. | total dose of nalbuphine administered to each patient as postoperative rescue analgesia for 36h. |
| Postoperative side effects as nausea, vomiting, bradycardia and hypotension | During the first 36 hours postoperatively. | incidence of Postoperative side effects as nausea, vomiting, bradycardia and hypotension. |
Countries
Egypt
Contacts
CONTACTNada sami abdelfattah mohammed, M.Sc.
CONTACTSherif Farouq Ibrahim El Shantory, Professor
Outcome results
None listed