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

Craniotomy Tumor Removal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04773093
• Other study ID #: IndonesiaUAnes057
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Indonesia University
• Contact: Aida Tantri
• Phone: +628161832487
• Email: aidatantri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniotomy Tumor Removal Surgery

Intervention

Drug:
• Continous 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
• Placebo
Patient will recieve Placebo NaCl 0.9% continuous intravenous infusion until the completion of surgery

Locations

Country	Name	City	State
Indonesia	National General Hospital Dr. Cipto Mangunkusumo	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

de Robles P, Fiest KM, Frolkis AD, Pringsheim T, Atta C, St Germaine-Smith C, Day L, Lam D, Jette N. The worldwide incidence and prevalence of primary brain tumors: a systematic review and meta-analysis. Neuro Oncol. 2015 Jun;17(6):776-83. doi: 10.1093/ne — View Citation

Dunbar PJ, Visco E, Lam AM. Craniotomy procedures are associated with less analgesic requirements than other surgical procedures. Anesth Analg. 1999 Feb;88(2):335-40. — View Citation

Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. Review. — View Citation

Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007. Review. — View Citation

Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Preoperative cognitive status	Measured by using MMSE questionnaire	During preanesthesia assessment
Primary	Postoperative cognitive status	Measured by using MMSE questionnaire	24-hours after surgery
Primary	Postoperative cognitive status	Measured by using MMSE questionnaire	36-hours after surgery