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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Postoperative MOCA Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manee Raksakietisak, M.D. | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Siriraj hospital, Mahidol University | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24137015 | Background | 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. | |
| 20821343 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group NSS | 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. |
| FG001 | Group Mg | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group NSS | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | ml | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. |
|
adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group NSS | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe brain edema | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor neurological complication | Nervous system disorders | Non-systematic Assessment | Seizure, CN palsy, Delirium, Hemiparesis, CSF leakage, Diabetes inspires (specific adverse event terms cannot be separated) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof. Manee Raksakietisak | Department of Anesthesiology, Faculty of medicine, Siriaj hospital, Mahidol University | +66814880620 | manee95@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2018 | Jun 6, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2018 | Jun 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
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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.
|
|
| 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. |
|
|
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 |
| 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. |
| Fentanyl Requirement | Amount of fentanyl usage during surgery | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. |
| 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. |
| 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. |
| 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. |
| 27599143 | 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. |
| 28283245 | 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. |
| 28584351 | 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. |
| 27803982 | 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. |
| 21364460 | 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. |
| 28494889 | 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. |
| 27840841 | 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. |
| 24649414 | 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. |
| 27123421 | 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. |
| 16670112 | 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. |
| 19199498 | 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. |
| 23562933 | 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. |
| 24105697 | 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. |
| 25824556 | 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. |
| 28930850 | 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. |
| Group Mg |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologist (ASA) | ASA I is normal healthy patient ASI II is a patient with mild systemic disease such obesity (BMI > 30), well controlled hypertension, well controlled DM, mild lung disease | Count of Participants | Participants |
|
| Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Baseline mean arterial pressure | Mean | Standard Deviation | mmHg |
|
| Single/multiple tumor | Count of Participants | Participants |
|
| Re-craniotomy | Count of Participants | Participants |
|
| Baseline MOCA scores | 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. | Median | Full Range | score on the MOCA scale |
|
|
|
|
| Secondary | Intraoperative Packed Red Cell (PRC) Transfusion | The amount of blood transfusion in patient who required PRC transfusion intraoperatively. | Posted | Median | Full Range | unit of packed red cell | 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. | There are some missing data due to patient's visual, hearing or writing problems that occurred postoperatively. | Posted | Median | Full Range | score on the MOCA scale | 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. | Posted | Mean | Standard Error | average minimum alveolar concentration | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. |
|
|
|
| Secondary | Fentanyl Requirement | Amount of fentanyl usage during surgery | Posted | Mean | Standard Error | mcg/kg/hr | 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 | Posted | Mean | Standard Error | mg/kg/hr | 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 | Posted | Count of Participants | Participants | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. |
|
|
|
| 0 |
| 38 |
| 1 |
| 38 |
| 17 |
| 38 |
| EG001 | Group Mg | 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. | 0 | 38 | 1 | 38 | 13 | 38 |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
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| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |