Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy.

Conditions
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Supratentorial Craniotomy Dysfunction

Intervention / Treatment
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* Drug: lidocaine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years old, ASA physical status I or II, BMI<30 Scheduled for elective supratentorial craniotomy MMSE<24 before operation Cooperative and given informed consent in person Exclusion Criteria: History of mental or psychiatric disorders Contraindicated to internal jugular venous catheterization Pregnant or lactating female History of systemic malignant tumor or diabetes Previously treated with this protocol or participated in another study within previous 30 days Suspected history of allergic reaction or intolerance to amides or other anesthetic agents in this study History of alcohol abuse and/or drug abuse within previous one year History or a family history of malignant hyperthermia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br> | Drug: saline<br>* Saline arm: infused at the same rate as lidocaine<br>|
| Active Comparator: Lidocaine<br> | Drug: lidocaine<br>* Lidocaine arm: lidocaine (2%) as an intravenous bolus (1.5 mg/kg) during induction followed by an intravenous infusion (2 mg. kg(-1).h(-1)) after induction until at the end of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination (MMSE) |  | Preoperatively, 3 days and 3 months postoperatively | 
| Montreal Cognitive Assessment (MoCA) |  | Preoperatively, 3 days and 3 months postoperatively | 
| Hamilton Depression Scale (HAMD) |  | Preoperatively, 3 days and 3 months postoperatively | 
| Clinical Dementia Rating (CDR) |  | Preoperatively, 3 days and 3 months postoperatively | 
| Confusion Assessment Method for the Diagnosis of Delirium in the Intensive Care unit (ICU) (CAM-ICU) |  | 1 day and 3 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AjDO2 (Arterial Jugular Difference) |  | Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery | 
| AjDGlc |  | Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery | 
| AjDGlutamate |  | Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery | 
| AjDLct |  | Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery | 
| S100 |  | Injection of test dosage, end of surgery, 24 hours after operation | 
| Amyloid-β protein(Aβ) |  | Injection of test dosage, end of surgery, 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supratentorial Craniotomy