Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rocuronium
研究概览
简要总结
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.
详细描述
Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Mg_orfil
patients preloaded with sodium valproate receives MgSO4 during the craniotomy.
干预措施: Magnesium Sulfate (Drug)
control_orfil
patients preloaded with sodium valproate receives 0.9% saline as placebo.
干预措施: 0.9% saline (Drug)
control_no orfil
patients not preloaded with sodium valproate receives 0.9% saline as placebo.
干预措施: 0.9% saline (Drug)
结局指标
主要结局
Rocuronium
时间窗: 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.
次要结局
- hemodynamics(participants will be followed 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..)
- Magnesium concentration(from the induction of anesthesia until 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.)
- pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use(patients will be followed from the end of the operation until postoperativ 48 h)
研究者
Kim Mihyun
clinical professor
Seoul National University Bundang Hospital