Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Study Overview
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Brief Summary
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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 inconclusive. 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.

Detailed Description
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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 normal saline group 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.

Official Title
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The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal

Conditions
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Meningioma

Intervention / Treatment
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* Drug: Magnesium group
* Drug: Normal saline group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnancy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium group<br>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 | Drug: Magnesium group<br>* 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.<br>* Other names: Mg;|
| Placebo Comparator: Normal saline group<br>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 | Drug: Normal saline group<br>* 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.<br>* Other names: NSS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood Loss | We measure the amount of blood loss in the operative room in suction box, gauze and plastic bag. The unit measure is millimeter. | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Packed Red Cell (PRC) Transfusion | The amount of blood transfusion in patient who required PRC transfusion intraoperatively. | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | 
| Postoperative MOCA Score | MOCA or Montreal Cognitive Assessment is a screening instrument used to facilitate the assessment of cognitive impairment. MOCA scores range between 0-30, do higher values represent a better outcome. A score of 26 or over is considered to be normal. We measure Montreal assessment score for assess cognitive function after operation at postoperative day 3-7. | Postoperative day 3-7 | 
| Sevoflurane Requirement | Amount of sevoflurane agents usage during surgery. The unit of measurement of volatile agent is minimum alveolar concentration (MAC). 1 MAC-hour was defined as 2% of sevoflurane for 1 hour duration. | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | 
| Fentanyl Requirement | Amount of fentanyl usage during surgery | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | 
| Cis-atracurium Requirement | Amount of cis-atracurium usage during surgery | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | 
| Patient Received Intraoperative Packed Red Cell (PRC) | Number of patients who required Intraoperative PRC transfusion | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningioma, Magnesium, Montreal cognitive assessment, blood loss, controlled hypotension, blood transfusion, neuroprotective, anesthesia