Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery

University of Indonesia (UI)

Status

Completed

Conditions

Anesthesia; Functional

Surgery

Haemodynamic Instability

Treatments

Drug: Adjuvant lidocaine continous

Drug: NaCl 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT06249113

IndonesiaUAnes1001

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

The patient's family or guardian refuses informed consent included in the research
The patient has atrioventricular block
There is a midline shift > 5.4 mm
Diagnosis of glioblastoma multiforme or metastases
History of allergies to drugs used in the study
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).
The patient has been regularly consuming analgesic agents for the past 2 weeks.
The patient has a history of cardiac arrhythmia, kidney or liver disease based on the results of the history and confirmed by further examination.
Suffering from diabetes mellitus or taking anti-drugs hyperglycemia based on preoperative assessment.