Clinical trial · Interventional
Effect of Continous Intravenous Lidocaine Infusion Intraoperative for Craniotomy Tumor Removal Surgery
Continous Intravenous Lidocaine Infusion Intraoperative for Craniotomy Tumor Removal Surgery: Effect to Brain Relaxation, Opioid Consumption and Postoperative Cognitive Status
NCT04773093CI-TRIAL-00050340unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craniotomy Tumor Removal Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continous Intravenous Lidocaine Infusion | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Continous Intravenous Lidocaine Infusion
- description
- Patient will recieve Continous Intravenous Lidocaine Infusion
- interventionNames
- Drug: Continous Intravenous Lidocaine Infusion
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patient will recieve placebo (NaCl 0.9% infusion)
- interventionNames
- Drug: Placebo
Primary outcomes (4)
- measure
- Brain relaxation
- timeFrame
- Up to 1 minute after duramater opening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (6)
- RESULTde 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
- RESULTFox 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
- RESULTDunn 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
- RESULTWeibel 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
- RESULTDunbar 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
- DERIVEDChandra 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