Meningioma is the most common central nervous system tumor and craniotomy with tumor removal was associated with moderate blood loss and blood transfusion. Magnesium has hypotensive effect and probably reduce intraoperative blood loss. Whether or not magnesium sulphate can reduce intraoperative blood loss and improve postoperative cognitive function is still inconlusive. So the investigators conduct the randomized control trial to compare the effect of magnesium with placebo control in blood loss and cognitive function in meningioma patient undergoing craniotomy.
Full Title of Study: “The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Study Primary Completion Date: June 1, 2020
The investigators enroll 120 patient who admitted for craniotomy for meningioma removal. Then, the patients will be divided into two groups. The first group or group Mg will receive magnesium sulphate 40 mg/kg infuse for 30 min (started at skin incision), and then infuse magnesium sulphate 10 mg/kg/hr until the dura will be closed. The another group or group NSS will receive the same amount of 0.9% sodium chloride. The anesthesia and surgery are standardized. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative Montreal cognitive assessment score.
- Drug: Magnesium group
- We will dilute magnesium 6 gram with 0.9% sodium chloride to 30 ml. The patient will receive magnesium sulfate 40 mg/kg infuse over 30 min started at skin incision and continuous drip 10 mg/kg/hr until the dura is closed. Anesthesia is standardized with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
- Drug: Normal saline group
- The patient will receive 0.9% sodium chloride the same amount of magnesium sulphate infuse over 30 min started at skin incision and continuous drip until the dura is closed. Anesthesia is standardized with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Arms, Groups and Cohorts
- Experimental: Magnesium group
- The patient will receive magnesium sulfate injection 40 mg/kg infuse over 30 min started at skin incision and continuous drip 10 mg/kg/hr until the dura is closed
- Placebo Comparator: Normal saline group
- The patient will receive 0.9% sodium chloride the same amount of magnesium sulphate infuse over 30 min started at skin incision and continuous drip until the dura is closed
Clinical Trial Outcome Measures
- Intraoperative blood loss
- Time Frame: Intraoperative period from skin was incised to the skin was closure
- We measure the amount of blood loss in the operative room in suction box, gauze and plastic bag. The unit measure is millimeter.
- Blood transfusion
- Time Frame: Intraoperative period from skin was incised to the skin was closure
- The amount of blood transfusion that the patient require intraoperatively. The unit measure is millimeter.
- Postoperative cognitive score
- Time Frame: 7 days
- We measure Montreal assessment score for assess cognitive function before and after operation (day5-7) or before being discharge. The total score is 30 and 26 or more is considered normal.
- Awakening time
- Time Frame: 2 hours
- Time from the patient receive reversal of muscle relaxant to time when patient can response to command
Participating in This Clinical Trial
- Meningioma patient
- Schedule for supratentorial craniotomy with tumor removal
- American society of anesthesiologists physical status 1-3
- Age 18-70 years
- No alteration of conscious (full Glasgow coma score) and well cooperate
- Expected to extubation after operation
- Unstable hemodynamic (severe hypotension or hypertension who receive antihypertensive and vasopressor before surgery but not include baseline oral antihypertensive drug)
- Known cardiac disease from either history, physical examination or investigation
- Patient who have heart block
- Hepatic disease (Child Pugh Score Class C)
- Renal insufficiency (eGFR < 60 ml/min from Chronic Kidney Disease Epidemiology Collaboration equation)
- Allergy to magnesium or other drugs use in the study
- Patient who receive calcium channel blocker drug
- Patient who receive magnesium for treatment such as arrhythmia or preeclampsia
- Hypermagnesemia (more than 2.6 mg/dL) before surgery
- BMI more than 30 kg/m2
- Patient who probably have brain herniation from increase intracranial pressure
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Mahidol University
- Provider of Information About this Clinical Study
- Overall Official(s)
- Manee Raksakietisak, M.D., Principal Investigator, Mahidol University
- Overall Contact(s)
- Manee Raksakietisak, M.D., +66814880620, email@example.com
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