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

University of Indonesia (UI)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Craniotomy Tumor Removal Surgery

Treatments: Drug: Continous Intravenous Lidocaine Infusion; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04773093

IndonesiaUAnes057

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 2 patient groups, including a placebo group

Continous Intravenous Lidocaine Infusion

Active Comparator group

Description:

Patient will recieve Continous Intravenous Lidocaine Infusion

Treatment:

Drug: Continous Intravenous Lidocaine Infusion

Placebo

Placebo Comparator group

Description:

Patient will recieve placebo (NaCl 0.9% infusion)

Treatment:

Drug: Placebo