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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
80
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.
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.
Faculty of medicine, Siriraj hospital, Mahidol University
Bangkok, Thailand
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.
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Intraoperative Packed Red Cell (PRC) Transfusion
The amount of blood transfusion in patient who required PRC transfusion intraoperatively.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Fentanyl Requirement
Amount of fentanyl usage during surgery
Time frame: 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
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
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Patient Received Intraoperative Packed Red Cell (PRC)
Number of patients who required Intraoperative PRC transfusion
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.