Cerebral Aneurysm
Conditions
Keywords
craniotomy, sodium valproate, rocuronium
Brief summary
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.
Detailed description
Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
Interventions
DRUGMagnesium Sulfate
MgSO4 infusion: 50mg/kg bolus followed by continuous infusion
DRUG0.9% saline
0.9% saline as same dose as MgSO4 as placebo
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18- 65 years * American society of anesthesiology physical status 1,2 * scheduled for elective craniotomy for aneurysm clipping or for superficial temporal artery-middle cerebral artery anastomosis
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rocuronium | participants will be followed for the duration of the surgery, an expected average of 5.5 hours. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnesium concentration | from the induction of anesthesia until end of the surgery | 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. |
| side effects | participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour. | complicaton associated with MgSO4 including muscle weakness, hot flush, and nausea/ vomiting. |
| hemodynamics | participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour | 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. |
| total amount of anesthetics | participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia.. | total amount of propofol and remifentanil infused is measured. |
| pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use | patients will be followed from the end of the operation until postoperativ 48 h | 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. |
Countries
South Korea
Contacts
Primary ContactMihyun Kim, Doctor
Outcome results
None listed