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Magnesium and Intraoperative Blood Loss in Meningioma Surgery

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ClinicalTrials.gov Identifier: NCT03558516
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Meningioma Drug: Magnesium group Drug: Normal saline group Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description: The study drug will prepared by the investigator in the same character and amount. So the patient and care provider will not know the study drug is magnesium or 0.9% sodium chloride.
Primary Purpose: Other
Official Title: The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : February 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Magnesium

Arm Intervention/treatment
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
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.
Other Name: Mg

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
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.
Other Name: NSS




Primary Outcome Measures :
  1. Intraoperative Blood Loss [ Time Frame: 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 :
  1. Intraoperative Packed Red Cell (PRC) Transfusion [ Time Frame: 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.

  2. Postoperative MOCA Score [ Time Frame: 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.


  3. Sevoflurane Requirement [ Time Frame: 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.

  4. Fentanyl Requirement [ Time Frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours. ]
    Amount of fentanyl usage during surgery

  5. Cis-atracurium Requirement [ Time Frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours. ]
    Amount of cis-atracurium usage during surgery

  6. Patient Received Intraoperative Packed Red Cell (PRC) [ Time Frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours. ]
    Number of patients who required Intraoperative PRC transfusion



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558516


Locations
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Thailand
Faculty of medicine, Siriraj hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Manee Raksakietisak, M.D. Mahidol University
  Study Documents (Full-Text)

Documents provided by Mahidol University:
Study Protocol  [PDF] August 1, 2018
Statistical Analysis Plan  [PDF] August 1, 2018

Publications:

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03558516    
Other Study ID Numbers: SI 259/2018
First Posted: June 15, 2018    Key Record Dates
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Meningioma
Magnesium
Montreal cognitive assessment
blood loss
controlled hypotension
blood transfusion
neuroprotective
anesthesia
Additional relevant MeSH terms:
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Meningioma
Hemorrhage
Pathologic Processes
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases