NCT03558516

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-02-03
• Completion: 2020-02-18
• First posted: 2018-06-15
• Last updated: 2020-07-13
• Results posted: 2020-07-13

Locations

1 site across 1 country: Thailand