Magnesium and Intraoperative Blood Loss in Meningioma Surgery

Meningioma Clinical Trial

Official title:

The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558516
• Other study ID #: SI 259/2018
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2018
• Est. completion date: February 18, 2020

Study information

• Verified date: June 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 18, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Meningioma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Faculty of medicine, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (17)

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. Review. — View Citation

Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. Epub 2006 May 2. — View 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. — View 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. Review. — View Citation

Herroeder S, Schönherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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:ii1-56. doi: 10.1093/neuonc/not151. Erratum in: Neuro Oncol. 2014 May;16(5):760. — View Citation

Rodríguez-Rubio L, Nava E, Del Pozo JSG, Jordán 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

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