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

Not Applicable

Completed

• Conditions: Surgery; Anesthesia; Functional; Haemodynamic Instability
• Interventions: Drug: NaCl 0.9%; Drug: Adjuvant lidocaine continous

• Registration Number: NCT06249113
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2023-01-16
• Primary Completion: 2023-11-23
• Study Completion: 2024-01-10
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-31
• Status Verified: 2024-02
• Study First Posted: 2024-02-08
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9% continous intravenous on tumor craniotomy surgery	NaCl 0.9%	NaCl 0.9% continous intravenous on general anesthesia during tumor craniotomy surgery
Adjuvant lidocaine continous intravenous on tumor craniotomy surgery	Adjuvant lidocaine continous	Adjuvant lidocaine continous intravenous on general anesthesia during tumor craniotomy surgery

Primary Outcome Measures

Name	Time	Method
Depth of Anaesthesia	Intraoperation	Depth of Anaesthesia measured by qCON index on CONOX monitor. qCON ranges from 0 to 99. A qCON index of more than 60 indicates inadequate use of sedative agents, whereas a qCON of less than 40 indicates excessive sedation
Pain Response	Intraoperation	Pain Response measured by qNOX index on CONOX monitor. The qNOX index uses a scale from 0 to 99 where 99 indicates a high probability of response to noxious stimulation. A decreasing index value means a smaller probability of response to the stimulus
Blood Sugar Levels	Intraoperation	Blood Sugar Levels measured by blood test during surgery

Secondary Outcome Measures

Name	Time	Method
Heart Rate	Intraoperation	Heart Rate (times/minutes) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing
Blood Pressure	Intraoperation	blood pressure (mm/Hg) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing. Blood Preasure includes systolic (mmHg), Diastolic (mmHg), and Mean Arterial Pressure (mmHg)
Body Temperature	Intraoperation	Body Temperature (celsius) shown on the monitor during surgery, induction, intubation, head pin installation, and skin incision, bone opening, dura mater opening, skin suturing

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia