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

NCT04773093 | Unknown Phase 1 DMC

• 1 other identifier: IndonesiaUAnes057
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Craniotomy Tumor Removal Surgery

Keywords

intravenous lidocaine; craniotomy; brain relaxation; opioid

Outcome Measures

Primary Outcomes (4)

• 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

• Preoperative cognitive status

  Measured by using MMSE questionnaire

  During preanesthesia assessment

• Postoperative cognitive status

  Measured by using MMSE questionnaire

  24-hours after surgery

• Postoperative cognitive status

  Measured by using MMSE questionnaire

  36-hours after surgery

Study Arms (2)

Continous Intravenous Lidocaine Infusion

ACTIVE COMPARATOR

Patient will recieve Continous Intravenous Lidocaine Infusion

Drug: Continous Intravenous Lidocaine Infusion

Placebo

PLACEBO COMPARATOR

Patient will recieve placebo (NaCl 0.9% infusion)

Drug: Placebo

Interventions

Continous Intravenous Lidocaine Infusion DRUG

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

Continous Intravenous Lidocaine Infusion

Placebo DRUG

Patient will recieve Placebo NaCl 0.9% continuous intravenous infusion until the completion of surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

National General Hospital Dr. Cipto Mangunkusumo

Jakarta Pusat, 10430, Indonesia

RECRUITING

Related Publications (6)

• 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/neuonc/nou283. Epub 2014 Oct 13.

  PMID: 25313193 RESULT

• 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.

  PMID: 21109143 RESULT

• Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.

  PMID: 28114177 RESULT

• 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;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

  PMID: 29864216 RESULT

• 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. doi: 10.1097/00000539-199902000-00021.

  PMID: 9972752 RESULT

• Chandra S, Pryambodho P, Omega A. Evaluation of continuous intravenous lidocaine on brain relaxation, intraoperative opioid consumption, and surgeon's satisfaction in adult patients undergoing craniotomy tumor surgery: A randomized controlled trial. Medicine (Baltimore). 2022 Sep 9;101(36):e30216. doi: 10.1097/MD.0000000000030227.

  PMID: 36086723 DERIVED

Central Study Contacts

Aida Tantri

CONTACT

+628161832487; aidatantri@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCA

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 26, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)