search
Back to results

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Primary Purpose

Meningioma

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Magnesium group
Normal saline group
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Meningioma focused on measuring Meningioma, Magnesium, Montreal cognitive assessment, blood loss, controlled hypotension, blood transfusion, neuroprotective, anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine, Siriraj hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium group

Normal saline group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraoperative Packed Red Cell (PRC) Transfusion
The amount of blood transfusion in patient who required PRC transfusion intraoperatively.
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.
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.
Fentanyl Requirement
Amount of fentanyl usage during surgery
Cis-atracurium Requirement
Amount of cis-atracurium usage during surgery
Patient Received Intraoperative Packed Red Cell (PRC)
Number of patients who required Intraoperative PRC transfusion

Full Information

First Posted
May 16, 2018
Last Updated
June 28, 2020
Sponsor
Mahidol University
search

1. Study Identification

Unique Protocol Identification Number
NCT03558516
Brief Title
Magnesium and Intraoperative Blood Loss in Meningioma Surgery
Official Title
The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
February 3, 2020 (Actual)
Study Completion Date
February 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma
Keywords
Meningioma, Magnesium, Montreal cognitive assessment, blood loss, controlled hypotension, blood transfusion, neuroprotective, anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium group
Arm Type
Experimental
Arm Description
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
Arm Title
Normal saline group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Magnesium group
Other Intervention Name(s)
Mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline group
Other Intervention Name(s)
NSS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative Blood Loss
Description
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.
Secondary Outcome Measure Information:
Title
Intraoperative Packed Red Cell (PRC) Transfusion
Description
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.
Title
Postoperative MOCA Score
Description
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
Title
Sevoflurane Requirement
Description
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.
Title
Fentanyl Requirement
Description
Amount of fentanyl usage during surgery
Time Frame
Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Title
Cis-atracurium Requirement
Description
Amount of cis-atracurium usage during surgery
Time Frame
Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Title
Patient Received Intraoperative Packed Red Cell (PRC)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Raksakietisak, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Siriraj hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24137015
Citation
Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, Stroup NE, Kruchko C, Barnholtz-Sloan JS. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013 Nov;15 Suppl 2(Suppl 2):ii1-56. doi: 10.1093/neuonc/not151. No abstract available. Erratum In: Neuro Oncol. 2014 May;16(5):760.
Results Reference
background
PubMed Identifier
20821343
Citation
Wiemels J, Wrensch M, Claus EB. Epidemiology and etiology of meningioma. J Neurooncol. 2010 Sep;99(3):307-14. doi: 10.1007/s11060-010-0386-3. Epub 2010 Sep 7.
Results Reference
background
PubMed Identifier
27599143
Citation
Goldbrunner R, Minniti G, Preusser M, Jenkinson MD, Sallabanda K, Houdart E, von Deimling A, Stavrinou P, Lefranc F, Lund-Johansen M, Moyal EC, Brandsma D, Henriksson R, Soffietti R, Weller M. EANO guidelines for the diagnosis and treatment of meningiomas. Lancet Oncol. 2016 Sep;17(9):e383-91. doi: 10.1016/S1470-2045(16)30321-7. Epub 2016 Aug 30.
Results Reference
background
PubMed Identifier
28283245
Citation
Hooda B, Chouhan RS, Rath GP, Bithal PK, Suri A, Lamsal R. Effect of tranexamic acid on intraoperative blood loss and transfusion requirements in patients undergoing excision of intracranial meningioma. J Clin Neurosci. 2017 Jul;41:132-138. doi: 10.1016/j.jocn.2017.02.053. Epub 2017 Mar 7.
Results Reference
background
PubMed Identifier
28584351
Citation
Soliman R, Fouad E. The effects of dexmedetomidine and magnesium sulphate in adult patients undergoing endoscopic transnasal transsphenoidal resection of pituitary adenoma: A double-blind randomised study. Indian J Anaesth. 2017 May;61(5):410-417. doi: 10.4103/ija.IJA_581_16.
Results Reference
background
PubMed Identifier
27803982
Citation
Kutlesic MS, Kutlesic RM, Mostic-Ilic T. Magnesium in obstetric anesthesia and intensive care. J Anesth. 2017 Feb;31(1):127-139. doi: 10.1007/s00540-016-2257-3. Epub 2016 Nov 1.
Results Reference
background
PubMed Identifier
21364460
Citation
Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
Results Reference
background
PubMed Identifier
28494889
Citation
Rodriguez-Rubio L, Nava E, Del Pozo JSG, Jordan J. Influence of the perioperative administration of magnesium sulfate on the total dose of anesthetics during general anesthesia. A systematic review and meta-analysis. J Clin Anesth. 2017 Jun;39:129-138. doi: 10.1016/j.jclinane.2017.03.038. Epub 2017 Apr 7.
Results Reference
background
PubMed Identifier
27840841
Citation
Modanlou Juibari H, Eftekharian HR, Arabion HR. Intravenous Magnesium Sulfate to Deliberate Hypotension and Bleeding after Bimaxillary Orthognathic Surgery; A Randomized Double-blind Controlled Trial. J Dent (Shiraz). 2016 Sep;17(3 Suppl):276-282.
Results Reference
background
PubMed Identifier
24649414
Citation
Ghodraty MR, Homaee MM, Farazmehr K, Nikzad-Jamnani AR, Soleymani-Dodaran M, Pournajafian AR, Nader ND. Comparative induction of controlled circulation by magnesium and remifentanil in spine surgery. World J Orthop. 2014 Jan 18;5(1):51-6. doi: 10.5312/wjo.v5.i1.51. eCollection 2014 Jan 18.
Results Reference
background
PubMed Identifier
27123421
Citation
Srivastava VK, Mishra A, Agrawal S, Kumar S, Sharma S, Kumar R. Comparative Evaluation of Dexmedetomidine and Magnesium Sulphate on Propofol Consumption, Haemodynamics and Postoperative Recovery in Spine Surgery: A Prospective, Randomized, Placebo Controlled, Double-blind Study. Adv Pharm Bull. 2016 Mar;6(1):75-81. doi: 10.15171/apb.2016.012. Epub 2016 Mar 17.
Results Reference
background
PubMed Identifier
16670112
Citation
Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. doi: 10.1093/bja/ael085. Epub 2006 May 2.
Results Reference
background
PubMed Identifier
19199498
Citation
Mack WJ, Kellner CP, Sahlein DH, Ducruet AF, Kim GH, Mocco J, Zurica J, Komotar RJ, Haque R, Sciacca R, Quest DO, Solomon RA, Connolly ES, Heyer EJ. Intraoperative magnesium infusion during carotid endarterectomy: a double-blind placebo-controlled trial. J Neurosurg. 2009 May;110(5):961-7. doi: 10.3171/2008.9.17671.
Results Reference
background
PubMed Identifier
23562933
Citation
Bilotta F, Gelb AW, Stazi E, Titi L, Paoloni FP, Rosa G. Pharmacological perioperative brain neuroprotection: a qualitative review of randomized clinical trials. Br J Anaesth. 2013 Jun;110 Suppl 1:i113-20. doi: 10.1093/bja/aet059. Epub 2013 Apr 5.
Results Reference
background
PubMed Identifier
24105697
Citation
Mathew JP, White WD, Schinderle DB, Podgoreanu MV, Berger M, Milano CA, Laskowitz DT, Stafford-Smith M, Blumenthal JA, Newman MF; Neurologic Outcome Research Group (NORG) of The Duke Heart Center. Intraoperative magnesium administration does not improve neurocognitive function after cardiac surgery. Stroke. 2013 Dec;44(12):3407-13. doi: 10.1161/STROKEAHA.113.002703. Epub 2013 Oct 8.
Results Reference
background
PubMed Identifier
25824556
Citation
Mirrahimi B, Mortazavi A, Nouri M, Ketabchi E, Amirjamshidi A, Ashouri A, Khajavi M, Mojtahedzadeh M. Effect of magnesium on functional outcome and paraclinical parameters of patients undergoing supratentorial craniotomy for brain tumors: a randomized controlled trial. Acta Neurochir (Wien). 2015 Jun;157(6):985-91; discussion 991. doi: 10.1007/s00701-015-2376-x. Epub 2015 Apr 1.
Results Reference
background
PubMed Identifier
28930850
Citation
Yang L, Wang HH, Wei FS, Ma LX. Evaluation of acute normovolemic hemodilution in patients undergoing intracranial meningioma resection: A quasi-experimental trial. Medicine (Baltimore). 2017 Sep;96(38):e8093. doi: 10.1097/MD.0000000000008093.
Results Reference
background

Learn more about this trial

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

We'll reach out to this number within 24 hrs