Meningioma
Conditions
Keywords
Meningioma, Magnesium, Montreal cognitive assessment, blood loss, controlled hypotension, blood transfusion, neuroprotective, anesthesia
Brief 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.
Interventions
DRUGMagnesium 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.
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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The study drug will prepared by the investigator in the same character and amount. So the patient and care provider will not know the study drug is magnesium or 0.9% sodium chloride.
Intervention model description
We compare intraoperative blood loss in two group between the magnesium (study group) and 0.9% sodium chloride group (control group)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Fentanyl Requirement | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | Amount of fentanyl usage during surgery |
| Cis-atracurium Requirement | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | Amount of cis-atracurium usage during surgery |
| Sevoflurane Requirement | 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. |
| Postoperative MOCA Score | 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. |
| Patient Received Intraoperative Packed Red Cell (PRC) | Intraoperative period from skin was incised to the skin was closure, an average 5 hours. | Number of patients who required Intraoperative PRC transfusion |
| Intraoperative Packed Red Cell (PRC) Transfusion | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group NSS The patients received normal saline with the same amount of magnesium sulphate for loading and continuous infusion started at skin incision until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics. | 38 |
| Group Mg The patients received 40 mg/kg of magnesium sulphate loading in 30 minutes at incision and then continuous drip 10 mg/kg/hr until dura was closure. Anesthesia was maintained with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics. | 38 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | Group Mg | Total | Group NSS |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 10.5 | 52 years STANDARD_DEVIATION 9.6 |
| American Society of Anesthesiologist (ASA) ASA I | 22 Participants | 47 Participants | 25 Participants |
| American Society of Anesthesiologist (ASA) ASA II | 16 Participants | 29 Participants | 13 Participants |
| Baseline mean arterial pressure | 93 mmHg STANDARD_DEVIATION 10 | 94 mmHg STANDARD_DEVIATION 11 | 95 mmHg STANDARD_DEVIATION 12 |
| Baseline MOCA scores | 23 score on the MOCA scale | 22 score on the MOCA scale | 21 score on the MOCA scale |
| Body Mass Index (BMI) | 23.3 kg/m^2 STANDARD_DEVIATION 3.2 | 23.6 kg/m^2 STANDARD_DEVIATION 3.4 | 23.8 kg/m^2 STANDARD_DEVIATION 3.6 |
| Hemoglobin | 13 g/dL STANDARD_DEVIATION 1.2 | 13 g/dL STANDARD_DEVIATION 1.4 | 13 g/dL STANDARD_DEVIATION 1.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Re-craniotomy | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Female | 34 Participants | 68 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
| Single/multiple tumor Multiple | 5 Participants | 9 Participants | 4 Participants |
| Single/multiple tumor Single | 33 Participants | 67 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 17 / 38 | 13 / 38 |
| serious Total, serious adverse events | 1 / 38 | 1 / 38 |
Outcome results
Primary
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.
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group NSS | Intraoperative Blood Loss | 510 ml |
| Group Mg | Intraoperative Blood Loss | 500 ml |
p-value: 0.315Wilcoxon (Mann-Whitney)
Secondary
Cis-atracurium Requirement
Amount of cis-atracurium usage during surgery
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group NSS | Cis-atracurium Requirement | 0.08 mg/kg/hr | Standard Error 0.02 |
| Group Mg | Cis-atracurium Requirement | 0.08 mg/kg/hr | Standard Error 0.01 |
Secondary
Fentanyl Requirement
Amount of fentanyl usage during surgery
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group NSS | Fentanyl Requirement | 0.65 mcg/kg/hr | Standard Error 0.19 |
| Group Mg | Fentanyl Requirement | 0.6 mcg/kg/hr | Standard Error 0.18 |
Secondary
Intraoperative Packed Red Cell (PRC) Transfusion
The amount of blood transfusion in patient who required PRC transfusion intraoperatively.
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group NSS | Intraoperative Packed Red Cell (PRC) Transfusion | 2 unit of packed red cell |
| Group Mg | Intraoperative Packed Red Cell (PRC) Transfusion | 1 unit of packed red cell |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Patient Received Intraoperative Packed Red Cell (PRC)
Number of patients who required Intraoperative PRC transfusion
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group NSS | Patient Received Intraoperative Packed Red Cell (PRC) | 10 Participants |
| Group Mg | Patient Received Intraoperative Packed Red Cell (PRC) | 7 Participants |
Secondary
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.
Time frame: Postoperative day 3-7
Population: There are some missing data due to patient's visual, hearing or writing problems that occurred postoperatively.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group NSS | Postoperative MOCA Score | 23 score on the MOCA scale |
| Group Mg | Postoperative MOCA Score | 25 score on the MOCA scale |
p-value: 0.299Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group NSS | Sevoflurane Requirement | 0.65 average minimum alveolar concentration | Standard Error 0.12 |
| Group Mg | Sevoflurane Requirement | 0.66 average minimum alveolar concentration | Standard Error 0.17 |