Craniotomy Tumor Removal Surgery
Conditions
Keywords
intravenous lidocaine, craniotomy, brain relaxation, opioid
Brief summary
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
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.
Interventions
DRUGContinous Intravenous Lidocaine Infusion
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
DRUGPlacebo
Patient will recieve Placebo NaCl 0.9% continuous intravenous infusion until the completion of surgery
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain relaxation | 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 |
| Preoperative cognitive status | During preanesthesia assessment | Measured by using MMSE questionnaire |
| Postoperative cognitive status | 24-hours after surgery | Measured by using MMSE questionnaire |
Countries
Indonesia
Contacts
Primary ContactAida Tantri
Outcome results
None listed