Clinical trial NCT00975910: Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Supratentorial Craniotomy Dysfunction
Keywords: Supratentorial Craniotomy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: State University of New York - Downstate Medical Center
First posted: 2009-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Preoperatively, 3 days and 3 months postoperatively
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Preoperatively, 3 days and 3 months postoperatively
measure: Hamilton Depression Scale (HAMD)
timeFrame: Preoperatively, 3 days and 3 months postoperatively
measure: Clinical Dementia Rating (CDR)
timeFrame: Preoperatively, 3 days and 3 months postoperatively
measure: Confusion Assessment Method for the Diagnosis of Delirium in the Intensive Care unit (ICU) (CAM-ICU)
timeFrame: 1 day and 3 days postoperatively
Secondary outcomes:
measure: AjDO2 (Arterial Jugular Difference)
timeFrame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
measure: AjDGlc
timeFrame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
measure: AjDGlutamate
timeFrame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
measure: AjDLct
timeFrame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
measure: S100
timeFrame: Injection of test dosage, end of surgery, 24 hours after operation
measure: Amyloid-β protein(Aβ)
timeFrame: Injection of test dosage, end of surgery, 24 hours after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: