Effect of Continous Intravenous Lidocaine Infusion Intraoperative for Craniotomy Tumor Removal Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Craniotomy Tumor Removal Surgery

Intervention / Treatment
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* Drug: Continous Intravenous Lidocaine Infusion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continous Intravenous Lidocaine Infusion<br>Patient will recieve Continous Intravenous Lidocaine Infusion | Drug: Continous Intravenous Lidocaine Infusion<br>* Patient will recieve intravenous Lidocaine dose 1.5 mg/kg at the time of induction and after that will receive maintenance by continous intravenous Lidocaine infusion dose 2 mg/kg/hour until the completion of surgery<br>|
| Placebo Comparator: Placebo<br>Patient will recieve placebo (NaCl 0.9% infusion) | Drug: Placebo<br>* Patient will recieve Placebo NaCl 0.9% continuous intravenous infusion until the completion of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain relaxation | 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 | Up to 1 minute after duramater opening | 
| Preoperative cognitive status | Measured by using MMSE questionnaire | During preanesthesia assessment | 
| Postoperative cognitive status | Measured by using MMSE questionnaire | 24-hours after surgery | 
| Postoperative cognitive status | Measured by using MMSE questionnaire | 36-hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous lidocaine, craniotomy, brain relaxation, opioid