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

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

Study Overview

• Status: Completed
• Conditions: Supratentorial Craniotomy Dysfunction
• Intervention / Treatment: Drug: saline; Drug: lidocaine

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Drug: saline; Saline arm: infused at the same rate as lidocaine
Active Comparator: Lidocaine	Drug: lidocaine; 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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
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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: State University of New York - Downstate Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 11, 2009
• First Posted (Estimate): September 14, 2009

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 21, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Supratentorial Craniotomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 20090801