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Completed

NCT Number: NCT00975910

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

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

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Key information

Conditions

Supratentorial Craniotomy Dysfunction

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Saline

Drug

Saline arm: infused at the same rate as lidocaine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • State University of New York - Downstate Medical Center

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2009
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.