NCT00975910CompletedPhase 2
Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy
Capital Medical University1 site in 1 country100 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mini-Mental State Examination (MMSE)
Study Overview
Brief Summary
The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Saline
Placebo Comparator
Intervention: saline (Drug)
Lidocaine
Active Comparator
Intervention: lidocaine (Drug)
Outcomes
Primary Outcomes
Mini-Mental State Examination (MMSE)
Time Frame: Preoperatively, 3 days and 3 months postoperatively
Montreal Cognitive Assessment (MoCA)
Time Frame: Preoperatively, 3 days and 3 months postoperatively
Hamilton Depression Scale (HAMD)
Time Frame: Preoperatively, 3 days and 3 months postoperatively
Clinical Dementia Rating (CDR)
Time Frame: Preoperatively, 3 days and 3 months postoperatively
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 Outcomes
- 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)
- Amyloid-β protein(Aβ)(Injection of test dosage, end of surgery, 24 hours after operation)
Investigators
Wei Zhang
attending
Capital Medical University
Study Sites (1)
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