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

NCT ID: NCT04773093

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Craniotomy Tumor Removal Surgery

Keywords

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intravenous lidocaine craniotomy brain relaxation opioid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Continous Intravenous Lidocaine Infusion

Patient will recieve Continous Intravenous Lidocaine Infusion

Group Type ACTIVE_COMPARATOR

Continous Intravenous Lidocaine Infusion

Intervention Type 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

Placebo

Patient will recieve placebo (NaCl 0.9% infusion)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Susilo Chandra

MD, FRCA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National General Hospital Dr. Cipto Mangunkusumo

Jakarta Pusat, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Aida Tantri

Role: CONTACT

Phone: +628161832487

Email: [email protected]

Facility Contacts

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Aida Tantri, MD, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 25313193 (View on PubMed)

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.

Reference Type RESULT
PMID: 21109143 (View on PubMed)

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

Reference Type RESULT
PMID: 28114177 (View on PubMed)

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.

Reference Type RESULT
PMID: 29864216 (View on PubMed)

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.

Reference Type RESULT
PMID: 9972752 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36086723 (View on PubMed)

Other Identifiers

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IndonesiaUAnes057

Identifier Type: -

Identifier Source: org_study_id