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

Phase 1

• Conditions: Craniotomy Tumor Removal Surgery
• Interventions: Drug: Continous Intravenous Lidocaine Infusion; Drug: Placebo

• Registration Number: NCT04773093
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-24
• Last Update Submitted: 2021-02-24
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continous Intravenous Lidocaine Infusion	Continous Intravenous Lidocaine Infusion	Patient will recieve Continous Intravenous Lidocaine Infusion
Placebo	Placebo	Patient will recieve placebo (NaCl 0.9% infusion)

Primary Outcome Measures

Name	Time	Method
Preoperative cognitive status	During preanesthesia assessment	Measured by using MMSE questionnaire
Postoperative cognitive status	36-hours after surgery	Measured by using MMSE questionnaire
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

Trial Locations

Locations (1)

National General Hospital Dr. Cipto Mangunkusumo; 🇮🇩 Jakarta Pusat, Indonesia