Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Phase 3

Completed

• Conditions: Meningioma
• Interventions: Drug: Normal saline group; Drug: Magnesium group

• Registration Number: NCT03558516
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Study Start: 2018-08-01
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-18
• Status Verified: 2020-06
• Results First Submitted: 2020-06-07
• Results First Submitted QC: 2020-06-28
• Last Update Submitted: 2020-06-28
• Results First Posted: 2020-07-13
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline group	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
Magnesium group	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intraoperative Packed Red Cell (PRC) Transfusion	Intraoperative period from skin was incised to the skin was closure, an average 5 hours.	The amount of blood transfusion in patient who required PRC transfusion intraoperatively.
Fentanyl Requirement	Intraoperative period from skin was incised to the skin was closure, an average 5 hours.	Amount of fentanyl usage during surgery
Cis-atracurium Requirement	Intraoperative period from skin was incised to the skin was closure, an average 5 hours.	Amount of cis-atracurium usage during surgery
Sevoflurane Requirement	Intraoperative period from skin was incised to the skin was closure, an average 5 hours.	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.
Postoperative MOCA Score	Postoperative day 3-7	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.
Patient Received Intraoperative Packed Red Cell (PRC)	Intraoperative period from skin was incised to the skin was closure, an average 5 hours.	Number of patients who required Intraoperative PRC transfusion

Trial Locations

Locations (1)

Faculty of medicine, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand