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

Capital Medical University

Status and phase: Completed; Phase 2

Conditions: Supratentorial Craniotomy Dysfunction

Treatments: Drug: saline; Drug: lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00975910

20090801

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Treatment:

Drug: saline

Lidocaine

Active Comparator group

Treatment:

Drug: lidocaine