Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery
NCT ID: NCT06249113
Last Updated: 2024-02-16
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-01-16
2024-01-10
Brief Summary
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Detailed Description
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The method is a Double-Blinded Randomized Control Trial. 60 patients aged 18-65 years who were diagnosed with craniotomy supratentorial tumor were randomly allocated to either Adjuvant Continuous Lidocaine (intervention group) or Normal Saline 0.9% (control group). Both drugs are given in a 20 ml syringe. The primary outcome measure of the study was the intraoperative of qCON, qNOX, and Blood Sugar. While the secondary outcome was the intraoperative hemodynamic.
All patients will be induced by general anesthesia using fentanyl 3 μg/kg IV as coinduction and propofol 1 mg/kg until the patient falls asleep. After induction, patients who receive lidocaine will receive a continuous intravenous infusion of 2 mg/kg/hour of lidocaine while other patients are given 0.9% NaCl as control. All patients data of hemodynamics, qCon, QNox, and blood glucose recorded and will be analyze.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NaCl 0.9% continous intravenous on tumor craniotomy surgery
NaCl 0.9% continous intravenous on general anesthesia during tumor craniotomy surgery
NaCl 0.9%
NaCl 0.9% continous intravenous on tumor craniotomy surgery
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Adjuvant lidocaine continous intravenous on general anesthesia during tumor craniotomy surgery
Adjuvant lidocaine continous
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Interventions
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NaCl 0.9%
NaCl 0.9% continous intravenous on tumor craniotomy surgery
Adjuvant lidocaine continous
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA physical status 1-3
* Surgery using a head pin
* The level of consciousness was assessed with the Glasgow Coma Scale 15
Exclusion Criteria
2. The patient has atrioventricular block
3. There is a midline shift \> 5.4 mm
4. Diagnosis of glioblastoma multiforme or metastases
5. History of allergies to drugs used in the study
6. The patient routinely consumes or is administered class of drugs adrenergic agonists or antagonists (e.g., beta blockers, α-2 agonists, vasodilator, vasoconstrictor or inotropic).
7. The patient has been regularly consuming analgesic agents for the past 2 weeks.
8. The patient has a history of cardiac arrhythmia, kidney or liver disease based on the results of the history and confirmed by further examination.
9. Suffering from diabetes mellitus or taking anti-drugs hyperglycemia based on preoperative assessment.
18 Years
65 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Arief Cahyadi
Anestesiologist, Principal Investigator
Principal Investigators
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Arief Cahyadi, Specialist
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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References
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Related Links
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Neuro-anesthetic Management of Craniotomy-surgery in Removal Tumor Multiple Meningioma Patients: A Case Report
Effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage in modified radical mastectomy: a randomized trial
Acute stress-induced changes in hormone and lipid levels in mouse plasma
Efek Pemberian Lidokain Intravena Kontinu Intraoperasi terhadap Kebutuhan Isofluran dan Pemakaian Fentanil pada Operasi Dekompresi dan Stabilisasi Posterior Vertebra
Other Identifiers
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IndonesiaUAnes1001
Identifier Type: -
Identifier Source: org_study_id
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