Supratentorial Craniotomy Dysfunction
Conditions
Keywords
Supratentorial Craniotomy
Brief summary
The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy.
Interventions
DRUGlidocaine
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
DRUGsaline
Saline arm: infused at the same rate as lidocaine
Sponsors
State University of New York - Downstate Medical Center
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| AjDO2 (Arterial Jugular Difference) | Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery |
| Amyloid-β protein(Aβ) | Injection of test dosage, end of surgery, 24 hours after operation |
| 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 |
Countries
China
Outcome results
None listed