MeningiomaPhase 3NCT03558516
Magnesium and Intraoperative Blood Loss in Meningioma Surgery
A Phase 3 study testing Magnesium group and Normal saline group in people with Meningioma, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meningioma
- What is being tested?
- Magnesium group and Normal saline group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2018to 18 Feb 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Official title: The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal
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.
Read the 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.
- Conditions
- Meningioma
- Being tested
- Magnesium group, Normal saline group
- Keywords
- Meningioma, Magnesium, Montreal cognitive assessment, blood loss, controlled hypotension, blood transfusion, neuroprotective, anesthesia
- Medical subject headings
- Meningioma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium groupDrug
Also called Mg
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 groupDrug
Also called NSS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Normal saline group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Secondary outcomes (6)
Intraoperative Packed Red Cell (PRC) Transfusion
The amount of blood transfusion in patient who required PRC transfusion intraoperatively.
Measured: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
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.
Measured: 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.
Measured: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Fentanyl Requirement
Amount of fentanyl usage during surgery
Measured: 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
Measured: 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
Measured: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Aug 2018
- Primary completion3 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manee Raksakietisak, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558516
- Sponsor's protocol ID
- SI 259/2018
- Status last verified
- Jun 2020
- First submitted
- 16 May 2018
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24137015Wiemels 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.
PubMed 20821343Goldbrunner 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.
PubMed 27599143Hooda 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.
PubMed 28283245Soliman 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.
PubMed 28584351Kutlesic 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.
PubMed 27803982Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
PubMed 21364460Rodriguez-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.
PubMed 28494889Modanlou 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.
PubMed 27840841Ghodraty 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.
PubMed 24649414Srivastava 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.
PubMed 27123421Elsharnouby 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.
PubMed 16670112Mack 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.
PubMed 19199498Bilotta 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.
PubMed 23562933Mathew 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.
PubMed 24105697
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Sulphate on Intraoperative Blood Loss in Meningioma Patient Undergoing Craniotomy With Tumor Removal
- ClinicalTrials.gov ID
- NCT03558516
- Acronym / sponsor ID
- SI 259/2018
- Conditions
- Meningioma
- Keywords
- Meningioma, Magnesium, Montreal cognitive assessment, blood loss, controlled hypotension, blood transfusion, neuroprotective, anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
| Arm | Type | Receives |
|---|---|---|
| Magnesium group | Experimental | Drug: Magnesium groupThe 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 | Drug: Normal saline groupThe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium groupAlso: MgWe 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. | Drug | Magnesium group |
| Normal saline groupAlso: NSSThe 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. | Drug | Normal saline group |
Primary outcome
Intraoperative Blood Loss
Time frame: 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.
6 secondary outcomes
Intraoperative Packed Red Cell (PRC) Transfusion
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Postoperative MOCA Score
Time frame: Postoperative day 3-7
Sevoflurane Requirement
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Fentanyl Requirement
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Cis-atracurium Requirement
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Patient Received Intraoperative Packed Red Cell (PRC)
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24137015Ostrom 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.
- Background: PubMed 20821343Wiemels 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.
- Background: PubMed 27599143Goldbrunner 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.
- Background: PubMed 28283245Hooda 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.
- Background: PubMed 28584351Soliman 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.
- Background: PubMed 27803982Kutlesic 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.
- Background: PubMed 21364460Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.
- Background: PubMed 28494889Rodriguez-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.
- Background: PubMed 27840841Modanlou 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.
- Background: PubMed 24649414Ghodraty 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.
- Background: PubMed 27123421Srivastava 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.
- Background: PubMed 16670112Elsharnouby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manee Raksakietisak, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium group and Normal saline group in people with Meningioma, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558516, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.