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

NCT00975910 | Completed Phase 2 DMC

• 1 other identifier: 20090801
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Supratentorial Craniotomy Dysfunction

Keywords

Supratentorial Craniotomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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

Study Arms (2)

Saline

PLACEBO COMPARATOR

Drug: saline

Lidocaine

ACTIVE COMPARATOR

Drug: lidocaine

Interventions

lidocaine 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

Lidocaine

saline DRUG

Saline arm: infused at the same rate as lidocaine

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead
• State University of New York - Downstate Medical Center: collaborator

Study Sites (1)

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 22, 2013

Record last verified: 2013-05

Locations

CN (1)