ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03558516
Recruitment Status : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
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 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.

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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 ]
    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. 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.

  2. 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.

  3. Awakening time [ Time Frame: 2 hours ]
    Time from the patient receive reversal of muscle relaxant to time when patient can response to command



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


Contacts
Contact: Manee Raksakietisak, M.D. +66814880620 manee95@hotmail.com
Contact: Thanawut Jitsinthunun, M.D. +66816291621 all_time_friend@hotmail.com

Locations
Thailand
Faculty of medicine, Siriraj hospital, Mahidol University Not yet recruiting
Bangkok, Thailand, 10700
Contact: Manee Raksakietisak, M.D.    +66814880620    manee95@hotmail.com   
Contact: Thanawut Jitsinthunun, M.D.    +66816291621    all_time_friend@hotmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Manee Raksakietisak, M.D. Mahidol University

Publications:

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03558516     History of Changes
Other Study ID Numbers: SI 259/2018
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 sulphate
Montreal cognitive assessment
Intraoperative blood loss

Additional relevant MeSH terms:
Hemorrhage
Meningioma
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
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents