Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Wei Zhang, Capital Medical University
ClinicalTrials.gov Identifier:
NCT00975910
First received: September 11, 2009
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Supratentorial Craniotomy Dysfunction
Drug: lidocaine
Drug: saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

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

Secondary Outcome Measures:
  • AjDO2 (Arterial Jugular Difference) [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ] [ Designated as safety issue: Yes ]
  • AjDGlc [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ] [ Designated as safety issue: Yes ]
  • AjDGlutamate [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ] [ Designated as safety issue: Yes ]
  • AjDLct [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery ] [ Designated as safety issue: Yes ]
  • S100 [ Time Frame: Injection of test dosage, end of surgery, 24 hours after operation ] [ Designated as safety issue: Yes ]
  • Amyloid-β protein(Aβ) [ Time Frame: Injection of test dosage, end of surgery, 24 hours after operation ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wei Zhang, attending, Capital Medical University
ClinicalTrials.gov Identifier: NCT00975910     History of Changes
Other Study ID Numbers: 20090801
Study First Received: September 11, 2009
Last Updated: May 21, 2013
Health Authority: China: Ethics Committee

Keywords provided by Capital Medical University:
Supratentorial Craniotomy

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014