Trial Outcomes & Findings for Magnesium and Intraoperative Blood Loss in Meningioma Surgery (NCT NCT03558516)
NCT ID: NCT03558516
Last Updated: 2020-07-13
Results Overview
We measure the amount of blood loss in the operative room in suction box, gauze and plastic bag. The unit measure is millimeter.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Intraoperative period from skin was incised to the skin was closure, an average 5 hours.
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 9.6 • n=38 Participants
|
47 years
STANDARD_DEVIATION 11 • n=38 Participants
|
50 years
STANDARD_DEVIATION 10.5 • n=76 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=38 Participants
|
34 Participants
n=38 Participants
|
68 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=38 Participants
|
4 Participants
n=38 Participants
|
8 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
23.8 kg/m^2
STANDARD_DEVIATION 3.6 • n=38 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 3.2 • n=38 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 3.4 • n=76 Participants
|
|
American Society of Anesthesiologist (ASA)
ASA I
|
25 Participants
n=38 Participants
|
22 Participants
n=38 Participants
|
47 Participants
n=76 Participants
|
|
American Society of Anesthesiologist (ASA)
ASA II
|
13 Participants
n=38 Participants
|
16 Participants
n=38 Participants
|
29 Participants
n=76 Participants
|
|
Hemoglobin
|
13 g/dL
STANDARD_DEVIATION 1.5 • n=38 Participants
|
13 g/dL
STANDARD_DEVIATION 1.2 • n=38 Participants
|
13 g/dL
STANDARD_DEVIATION 1.4 • n=76 Participants
|
|
Baseline mean arterial pressure
|
95 mmHg
STANDARD_DEVIATION 12 • n=38 Participants
|
93 mmHg
STANDARD_DEVIATION 10 • n=38 Participants
|
94 mmHg
STANDARD_DEVIATION 11 • n=76 Participants
|
|
Single/multiple tumor
Single
|
34 Participants
n=38 Participants
|
33 Participants
n=38 Participants
|
67 Participants
n=76 Participants
|
|
Single/multiple tumor
Multiple
|
4 Participants
n=38 Participants
|
5 Participants
n=38 Participants
|
9 Participants
n=76 Participants
|
|
Re-craniotomy
|
8 Participants
n=38 Participants
|
10 Participants
n=38 Participants
|
18 Participants
n=76 Participants
|
|
Baseline MOCA scores
|
21 score on the MOCA scale
n=38 Participants
|
23 score on the MOCA scale
n=38 Participants
|
22 score on the MOCA scale
n=76 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
|---|---|---|
|
Intraoperative Blood Loss
|
510 ml
Interval 100.0 to 1600.0
|
500 ml
Interval 70.0 to 2300.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
|---|---|---|
|
Intraoperative Packed Red Cell (PRC) Transfusion
|
2 unit of packed red cell
Interval 1.0 to 4.0
|
1 unit of packed red cell
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Postoperative day 3-7Population: There are some missing data due to patient's visual, hearing or writing problems that occurred postoperatively.
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.
Outcome measures
| Measure |
Group NSS
n=15 Participants
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.
|
Group Mg
n=16 Participants
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.
|
|---|---|---|
|
Postoperative MOCA Score
|
23 score on the MOCA scale
Interval 15.0 to 28.0
|
25 score on the MOCA scale
Interval 8.0 to 30.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
|---|---|---|
|
Sevoflurane Requirement
|
0.65 average minimum alveolar concentration
Standard Error 0.12
|
0.66 average minimum alveolar concentration
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.Amount of fentanyl usage during surgery
Outcome measures
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
|---|---|---|
|
Fentanyl Requirement
|
0.65 mcg/kg/hr
Standard Error 0.19
|
0.6 mcg/kg/hr
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.Amount of cis-atracurium usage during surgery
Outcome measures
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
|---|---|---|
|
Cis-atracurium Requirement
|
0.08 mg/kg/hr
Standard Error 0.02
|
0.08 mg/kg/hr
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Intraoperative period from skin was incised to the skin was closure, an average 5 hours.Number of patients who required Intraoperative PRC transfusion
Outcome measures
| Measure |
Group NSS
n=38 Participants
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.
|
Group Mg
n=38 Participants
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.
|
|---|---|---|
|
Patient Received Intraoperative Packed Red Cell (PRC)
|
10 Participants
|
7 Participants
|
Adverse Events
Group NSS
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Group Mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group NSS
n=38 participants at risk
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.
|
Group Mg
n=38 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Severe brain edema
|
2.6%
1/38 • Number of events 1 • adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
|
2.6%
1/38 • Number of events 1 • adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
|
Other adverse events
| Measure |
Group NSS
n=38 participants at risk
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.
|
Group Mg
n=38 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Minor neurological complication
|
26.3%
10/38 • adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
|
31.6%
12/38 • adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
|
|
Infections and infestations
Infection
|
18.4%
7/38 • adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
|
2.6%
1/38 • adverse event that occurred in the operating room until discharge from hospital, an average 8 days but maximum is 35 days
|
Additional Information
Assoc. Prof. Manee Raksakietisak
Department of Anesthesiology, Faculty of medicine, Siriaj hospital, Mahidol University
Phone: +66814880620
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place