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Clinical Trials/NCT04773093
NCT04773093
Unknown
Phase 1

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

Indonesia University1 site in 1 country50 target enrollmentJanuary 1, 2021

Overview

Phase
Phase 1
Intervention
Continous Intravenous Lidocaine Infusion
Conditions
Craniotomy Tumor Removal Surgery
Sponsor
Indonesia University
Enrollment
50
Locations
1
Primary Endpoint
Preoperative cognitive status
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susilo Chandra

MD, FRCA

Indonesia University

Eligibility Criteria

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

Arms & Interventions

Continous Intravenous Lidocaine Infusion

Patient will recieve Continous Intravenous Lidocaine Infusion

Intervention: Continous Intravenous Lidocaine Infusion

Placebo

Patient will recieve placebo (NaCl 0.9% infusion)

Intervention: Placebo

Outcomes

Primary Outcomes

Preoperative cognitive status

Time Frame: During preanesthesia assessment

Measured by using MMSE questionnaire

Postoperative cognitive status

Time Frame: 36-hours after surgery

Measured by using MMSE questionnaire

Brain relaxation

Time Frame: 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

Study Sites (1)

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