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The investigators hypothesized that valproic acid will increase rocuronium requirement and MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded with sodium valproate.
Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mg_orfil | Experimental | patients preloaded with sodium valproate receives MgSO4 during the craniotomy. |
|
| control_orfil | Placebo Comparator | patients preloaded with sodium valproate receives 0.9% saline as placebo. |
|
| control_no orfil | Placebo Comparator | patients not preloaded with sodium valproate receives 0.9% saline as placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | MgSO4 infusion: 50mg/kg bolus followed by continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rocuronium | Roc 0.15mg/kg is injected when train of four (TOF) becomes 2 which is measured with TOF-watch Sx. The total amount of Roc that injected is recorded. The intervals of each Roc 0.15mg/kg injection will also be recorded. | participants will be followed for the duration of the surgery, an expected average of 5.5 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| hemodynamics | mean arterial pressure and heart rate is measured for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour. | participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour |
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Inclusion Criteria:
Exclusion Criteria:
body mass index <18.5 or >24.9 kg m-2; neuromuscular, renal, cardiovascular or hepatic insufficiency; Glasgow coma scale (GCS) <15; allergy to the study drugs; medications influencing NDMRs; breast feeding; pregnancy; and preoperative epilepsy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mihyun Kim, Doctor | Contact | 82-31-787-7499 | snmd56@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanghwan Do, Doctor | Seoul National University Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang hopital | Recruiting | Seongnam-si | Gyeonggi-do | 463-787 | South Korea |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| 0.9% saline | Drug | 0.9% saline as same dose as MgSO4 as placebo |
|
|
| 0.9% saline | Drug | 0.9% saline as same dose as MgSO4 as placebo |
|
|
| total amount of anesthetics |
total amount of propofol and remifentanil infused is measured. |
| participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia.. |
| Magnesium concentration | serum Magnesium concentration is measured just prior to anesthetic drug administration, 3 hour after the induction of anesthesia, and at the end of the surgery. | from the induction of anesthesia until end of the surgery |
| side effects | complicaton associated with MgSO4 including muscle weakness, hot flush, and nausea/ vomiting. | participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour. |
| pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use | Pain will be assessed using numeric rating scale at 6 h, 24 h, and 48 h postoperately. Cumulative dose of analgesics and nicardipine, incidence of nicardipine and antiemtics use during 48h postoperatively will be recorded. | patients will be followed from the end of the operation until postoperativ 48 h |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |