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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continous Intravenous Lidocaine Infusion | Active Comparator | Patient will recieve Continous Intravenous Lidocaine Infusion |
|
| Placebo | Placebo Comparator | Patient will recieve placebo (NaCl 0.9% infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aida Tantri | Contact | +628161832487 | aidatantri@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National General Hospital Dr. Cipto Mangunkusumo | Recruiting | Jakarta Pusat | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25313193 | Result | 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. | |
| 21109143 | 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. |
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| Placebo | Drug | Patient will recieve Placebo NaCl 0.9% continuous intravenous infusion until the completion of surgery |
|
| 28114177 | 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. |
| 29864216 | 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. |
| 9972752 | 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. |
| 36086723 | Derived | 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. |