Magnesium and Intraoperative Blood Loss in Meningioma Surgery

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03558516
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.6
• Patients Per Site Per Month: 4.3

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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)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: Aug 1, 2018
• Actual Primary Completion Date: Feb 3, 2020
• Actual Study Completion Date: Feb 18, 2020

Arms and Interventions

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 Names: 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 Names: NSS

Outcome Measures

Primary Outcome Measures

1. Intraoperative Blood Loss [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 [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 [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 [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 [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 [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) [Intraoperative period from skin was incised to the skin was closure, an average 5 hours.]

   Number of patients who required Intraoperative PRC transfusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Siriraj hospital, Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Manee Raksakietisak, M.D., Mahidol University

Study Documents (Full-Text)

• Study Protocol - Aug 1, 2018
• Statistical Analysis Plan - Aug 1, 2018

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03558516
• Other Study ID Numbers: SI 259/2018
• First Posted: Jun 15, 2018
• Last Update Posted: Jul 13, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Meningioma; Hemorrhage

Study Results

Participant Flow

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Period Title: Overall Study
STARTED	40	40
COMPLETED	38	38
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Group NSS	Group Mg	Total
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	Total of all reporting groups
Overall Participants	38	38	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (9.6)	47 (11)	50 (10.5)
Sex: Female, Male (Count of Participants)
Female	34 89.5%	34 89.5%	68 89.5%
Male	4 10.5%	4 10.5%	8 10.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.8 (3.6)	23.3 (3.2)	23.6 (3.4)
American Society of Anesthesiologist (ASA) (Count of Participants)
ASA I	25 65.8%	22 57.9%	47 61.8%
ASA II	13 34.2%	16 42.1%	29 38.2%
Hemoglobin (g/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/dL]	13 (1.5)	13 (1.2)	13 (1.4)
Baseline mean arterial pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	95 (12)	93 (10)	94 (11)
Single/multiple tumor (Count of Participants)
Single	34 89.5%	33 86.8%	67 88.2%
Multiple	4 10.5%	5 13.2%	9 11.8%
Re-craniotomy (Count of Participants)
Count of Participants [Participants]	8 21.1%	10 26.3%	18 23.7%
Baseline MOCA scores (score on the MOCA scale) [Median (Full Range) ]
Median (Full Range) [score on the MOCA scale]	21	23	22

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	38	38
Median (Full Range) [ml]	510	500

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group NSS, Group Mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.315
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	38	38
Median (Full Range) [unit of packed red cell]	2	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group NSS, Group Mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.270
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

There are some missing data due to patient's visual, hearing or writing problems that occurred postoperatively.

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	15	16
Median (Full Range) [score on the MOCA scale]	23	25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group NSS, Group Mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.299
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	38	38
Mean (Standard Error) [average minimum alveolar concentration]	0.65 (0.12)	0.66 (0.17)

5. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	38	38
Mean (Standard Error) [mcg/kg/hr]	0.65 (0.19)	0.6 (0.18)

6. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	38	38
Mean (Standard Error) [mg/kg/hr]	0.08 (0.02)	0.08 (0.01)

7. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group NSS	Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.	The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
Measure Participants	38	38
Count of Participants [Participants]	10 26.3%	7 18.4%

Adverse Events

Time Frame	adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
Arm/Group Title	Group NSS		Group Mg
Arm/Group Description	The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.		The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
All Cause Mortality
	Group NSS		Group Mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/38 (0%)		0/38 (0%)
Serious Adverse Events
	Group NSS		Group Mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/38 (2.6%)		1/38 (2.6%)
Nervous system disorders
Severe brain edema	1/38 (2.6%)	1	1/38 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Group NSS		Group Mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/38 (44.7%)		13/38 (34.2%)
Infections and infestations
Infection	7/38 (18.4%)		1/38 (2.6%)
Nervous system disorders
Minor neurological complication	10/38 (26.3%)		12/38 (31.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.