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

NCT ID: NCT00975910

Last Updated: 2013-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Supratentorial Craniotomy Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Saline arm: infused at the same rate as lidocaine

Lidocaine

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

saline

Saline arm: infused at the same rate as lidocaine

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York - Downstate Medical Center

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhang

attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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20090801

Identifier Type: -

Identifier Source: org_study_id

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