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NCT Number: NCT03558516

Magnesium and Intraoperative Blood Loss in Meningioma Surgery

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.

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Key information

Conditions

Meningioma Central Nervous System Neoplasms Hemorrhage Meningeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of medicine, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mg

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.

Other names: NSS

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intraoperative Packed Red Cell (PRC) Transfusion

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

    Number of patients who required Intraoperative PRC transfusion

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2018
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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