Magnesium and Intraoperative Blood Loss in Meningioma Surgery

June 28, 2020 updated by: Mahidol University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of medicine, Siriraj hospital, Mahidol university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium group
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
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.
Other Names:
  • Mg
Placebo Comparator: 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
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.
Other Names:
  • NSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
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.
Postoperative day 3-7
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.
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.
Amount of fentanyl usage during surgery
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.
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)
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
Intraoperative period from skin was incised to the skin was closure, an average 5 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Manee Raksakietisak, M.D., Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

February 3, 2020

Study Completion (Actual)

February 18, 2020

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

June 28, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI 259/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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