Phase 3
N=80
Magnesium and Intraoperative Blood Loss in Meningioma Surgery
Meningioma
Bottom Line
View on ClinicalTrials.gov: NCT03558516 ↗Enrolled (actual)
80
Serious AEs
2.6%
Results posted
Jul 2020
Primary outcome: Primary: Intraoperative Blood Loss — 510; 500 ml — p=0.315
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Magnesium group (Drug); Normal saline group (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mahidol University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Blood Loss |
510; 500 | 0.315 |
| SECONDARY Intraoperative Packed Red Cell (PRC) Transfusion |
2; 1 | 0.270 |
| SECONDARY Postoperative MOCA Score |
23; 25 | 0.299 |
| SECONDARY Sevoflurane Requirement |
0.65; 0.66 | — |
| SECONDARY Fentanyl Requirement |
0.65; 0.6 | — |
| SECONDARY Cis-atracurium Requirement |
0.08; 0.08 | — |
| SECONDARY Patient Received Intraoperative Packed Red Cell (PRC) |
10; 7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03558516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.