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

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ClinicalTrials.gov Identifier: NCT00975910
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : May 22, 2013
Sponsor:
Collaborator:
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Wei Zhang, Capital Medical University

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

Condition or disease Intervention/treatment Phase
Supratentorial Craniotomy Dysfunction Drug: lidocaine Drug: saline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : September 2009
Primary Completion Date : May 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Mini-Mental State Examination (MMSE) [ Time Frame: Preoperatively, 3 days and 3 months postoperatively ]
  2. Montreal Cognitive Assessment (MoCA) [ Time Frame: Preoperatively, 3 days and 3 months postoperatively ]
  3. Hamilton Depression Scale (HAMD) [ Time Frame: Preoperatively, 3 days and 3 months postoperatively ]
  4. Clinical Dementia Rating (CDR) [ Time Frame: Preoperatively, 3 days and 3 months postoperatively ]
  5. Confusion Assessment Method for the Diagnosis of Delirium in the Intensive Care unit (ICU) (CAM-ICU) [ Time Frame: 1 day and 3 days postoperatively ]

Secondary Outcome Measures :
  1. AjDO2 (Arterial Jugular Difference) [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ]
  2. AjDGlc [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ]
  3. AjDGlutamate [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ]
  4. AjDLct [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ]
  5. S100 [ Time Frame: Injection of test dosage, end of surgery, 24 hours after operation ]
  6. Amyloid-β protein(Aβ) [ Time Frame: Injection of test dosage, end of surgery, 24 hours after operation ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975910


Locations
China, Beijing
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
State University of New York - Downstate Medical Center

Responsible Party: Wei Zhang, attending, Capital Medical University
ClinicalTrials.gov Identifier: NCT00975910     History of Changes
Other Study ID Numbers: 20090801
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Wei Zhang, Capital Medical University:
Supratentorial Craniotomy

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action