Continous Intravenous Lidocaine Infusion Intraoperative for Craniotomy Tumor Removal Surgery: Effect to Brain Relaxation, Opioid Consumption and Postoperative Cognitive Status
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Preoperative cognitive status
研究概览
简要总结
This study aimed to compare continous intravenous lidocaine infusion and placebo on the effect to brain relaxation, opioid consumption and postoperative cognitive status in adult patient undergoing craniotomy tumor removal surgery
详细描述
Fifty subjects were given informed consent one day before surgery and then randomized into two groups: continous intravenous Lidocaine intraoperative and Placebo. Patient, the Anesthesist as data collector, and the Neurosurgeon as the outcome assessor are blinded to the randomization and the intervention given. Non invasive blood pressure, ECG, and pulse oxymetry monitor were set on the subject in the operating room. General anesthesia induction was done by Fentanyl 3 mcg/kg, Lidocaine 1.5 mg/kg or Placebo (according to allocation group), Propofol 1-2 mg/kg and Rocuronium 1 mg/kg. After the intubation, maintenance continous intravenous Lidocain dose 2 mg/kg/hours or Placebo were set until the completion of surgery. Other than intervention (Lidocain or Placebo), maintenance was done by volatile Sevoflurane 0.8 -1.0 MAC, intermittent Fentanyl, continous Atracurium dose 5 mcg/kg/minutes and Manitol 20% dose 0.5 g/kg 30 minutes before Neurosurgeon reach the duramater. At the time Neurosurgeon reach the duramater, before and after they open the duramater, Neurosurgeon will assess brain relaxation by direct inspection and palpation. Total Fentanyl intraoperative will record and Cognitive status pre and postoperative will assess using MMSE. Postoperatively patient will transport to the ICU for monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult patient age 18-65 years old undergo craniotomy tumor removal surgery
- •Physical status ASA 1-3
- •Compos mentis (GCS 15)
- •Operation using pin head fixation
排除标准
- •Patient or family refused to participate
- •Has Atrioventricular block rhytm on ECG
- •Has sign of circulation shock
- •Midline shift > 5.4 mm on brain imaging
- •Diagnose with Glioblastoma multiforme or Metastatic
- •Vascular surgery
- •Using CSF drainage (EVD, VP shunt, or Lumbal drain)
- •Routine using or in treatmet using adrenergic agonist or antagonist drugs
- •Routine consumption of opioid in last two weeks before surgery
- •History of Local anesthetic hypersensitivity
研究组 & 干预措施
Continous Intravenous Lidocaine Infusion
Patient will recieve Continous Intravenous Lidocaine Infusion
干预措施: Continous Intravenous Lidocaine Infusion (Drug)
Placebo
Patient will recieve placebo (NaCl 0.9% infusion)
干预措施: Placebo (Drug)
结局指标
主要结局
Preoperative cognitive status
时间窗: During preanesthesia assessment
Measured by using MMSE questionnaire
Postoperative cognitive status
时间窗: 36-hours after surgery
Measured by using MMSE questionnaire
Brain relaxation
时间窗: Up to 1 minute after duramater opening
Measure by direct inspection and palpation of duramater and brain by Neurosurgeon. The result is using four points scale, grading the brain as completely relaxed, satisfactorily relaxed, firm and bulging
次要结局
未报告次要终点
研究者
Susilo Chandra
MD, FRCA
Indonesia University
