Magnesium and Intraoperative Blood Loss in Meningioma Surgery

NCT03558516 | Completed Phase 3 Results

• 1 other identifier: SI 259/2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningioma

Keywords

Meningioma; Magnesium; Montreal cognitive assessment; blood loss; controlled hypotension; blood transfusion; neuroprotective; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Secondary Outcomes (6)

• Intraoperative Packed Red Cell (PRC) Transfusion

  Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

• Postoperative MOCA Score

  Postoperative day 3-7

• Sevoflurane Requirement

  Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

• Fentanyl Requirement

  Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

• Cis-atracurium Requirement

  Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Study Arms (2)

Magnesium group

EXPERIMENTAL

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

Normal saline group

PLACEBO COMPARATOR

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

Interventions

Magnesium group DRUG

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.

Also known as: Mg

Magnesium group

Normal saline group DRUG

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.

Also known as: NSS

Normal saline group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of medicine, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (17)

• 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.

  PMID: 24137015 BACKGROUND

• 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.

  PMID: 20821343 BACKGROUND

• 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.

  PMID: 27599143 BACKGROUND

• 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.

  PMID: 28283245 BACKGROUND

• 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.

  PMID: 28584351 BACKGROUND

• 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.

  PMID: 27803982 BACKGROUND

• 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.

  PMID: 21364460 BACKGROUND

• 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.

  PMID: 28494889 BACKGROUND

• 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.

  PMID: 27840841 BACKGROUND

• 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.

  PMID: 24649414 BACKGROUND

• 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.

  PMID: 27123421 BACKGROUND

• 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.

  PMID: 16670112 BACKGROUND

• 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.

  PMID: 19199498 BACKGROUND

• 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.

  PMID: 23562933 BACKGROUND

• 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.

  PMID: 24105697 BACKGROUND

• 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.

  PMID: 25824556 BACKGROUND

• 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.

  PMID: 28930850 BACKGROUND

MeSH Terms

Conditions

Meningioma; Hemorrhage

Condition Hierarchy (Ancestors)

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Assoc. Prof. Manee Raksakietisak
• Organization: Department of Anesthesiology, Faculty of medicine, Siriaj hospital, Mahidol University

manee95@hotmail.com

+66814880620

Study Officials

• Manee Raksakietisak, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 15, 2018
• Study Start: August 1, 2018
• Primary Completion: February 3, 2020
• Study Completion: February 18, 2020
• Last Updated: July 13, 2020
• Results First Posted: July 13, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)