Clinical trial NCT06249113: Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery
Official title: Effectiveness of Adjuvant Continuous Lidocaine in General Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in Elective Primary Tumor Craniotomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anesthesia; Functional
Haemodynamic Instability
Keywords: Adjuvant Continuous Lidocaine
General Anesthesia
Depth of Anesthesia
Pain Response
Blood Sugar Levels
Elective Primary Tumor Craniotomy Surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of adjuvant continuous lidocaine in General Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in Elective Primary Tumor Craniotomy Surgery

Detailed description: Craniotomy for resection of brain tumors is frequently performed in neurosurgical practice. Craniotomy surgery is currently starting to use the Enhanced Recovery After Surgery (ERAS) protocol, namely for intraoperative pain management. Intraoperative pain can be evaluated through intraoperative hemodynamic conditions or can also use qCON and qNOX parameters and blood sugar levels. Perioperative pain management in the form of continuous intravenous lidocaine shows a role in reducing intraoperative pain. However, the use of intravenous lidocaine in ERAS protocols is still debated. So this study aims to use general anesthesia with continuous IV lidocaine adjuvant general anesthesia to affect depth of anesthesia (qCONtm) and intraoperative pain response in the form of values (qNOXtm), and blood sugar levels during elective primary tumor craniotomy.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 - 65 years with a diagnosis of brain tumor supratentorial who will undergo craniotomy by opening the dura
* ASA physical status 1-3
* Surgery using a head pin
* The level of consciousness was assessed with the Glasgow Coma Scale 15

Exclusion Criteria:

1. The patient's family or guardian refuses informed consent included in the research
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.

Primary outcomes:
measure: Depth of Anaesthesia
timeFrame: Intraoperation
measure: Pain Response
timeFrame: Intraoperation
measure: Blood Sugar Levels
timeFrame: Intraoperation
Secondary outcomes:
measure: Blood Pressure
timeFrame: Intraoperation
measure: Heart Rate
timeFrame: Intraoperation
measure: Body Temperature
timeFrame: Intraoperation
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Arief Cahyadi, Specialist
role: PRINCIPAL_INVESTIGATOR
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