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临床试验/NCT04773093
NCT04773093Unknown1 期

Continous Intravenous Lidocaine Infusion Intraoperative for Craniotomy Tumor Removal Surgery: Effect to Brain Relaxation, Opioid Consumption and Postoperative Cognitive Status

Indonesia University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patient will recieve Continous Intravenous Lidocaine Infusion

干预措施: Continous Intravenous Lidocaine Infusion (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susilo Chandra

MD, FRCA

Indonesia University

研究点 (1)

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