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

September 11, 2009
May 21, 2013
September 2009
May 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Mini-Mental State Examination (MMSE) [ Time Frame: Preoperatively, 1 day, 3 days and 3 months postoperatively ] [ Designated as safety issue: Yes ]
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Preoperatively, 1 day, 3 days and 3 months postoperatively ] [ Designated as safety issue: Yes ]
  • Hamilton Depression Scale (HAMD) [ Time Frame: Preoperatively, 1 day, 3 days and 3 months postoperatively ] [ Designated as safety issue: Yes ]
  • Clinical Dementia Rating (CDR) [ Time Frame: Preoperatively, 1 day, 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: Preoperatively, 1 day, 3 days and 3 months postoperatively ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00975910 on ClinicalTrials.gov Archive Site
  • 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 ]
  • AjDO2 (Arterial Jugular Difference) [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery, 24 hours after operation ] [ 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, 24 hours after operation ] [ 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, 24 hours after operation ] [ 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, 24 hours after operation ] [ Designated as safety issue: Yes ]
  • S100 [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery, 24 hours after operation ] [ Designated as safety issue: Yes ]
  • Amyloidβ-protein(Aβ) [ Time Frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery, 24 hours after operation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy
Not Provided

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Supratentorial Craniotomy Dysfunction
  • 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
  • Drug: saline
    Saline arm: infused at the same rate as lidocaine
  • Placebo Comparator: Saline
    Intervention: Drug: saline
  • Active Comparator: Lidocaine
    Intervention: Drug: lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00975910
20090801
Yes
Wei Zhang, Capital Medical University
Capital Medical University
State University of New York - Downstate Medical Center
Not Provided
Capital Medical University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP