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Sponsored by: |
Medical University of Gdansk |
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Information provided by: | Medical University of Gdansk |
ClinicalTrials.gov Identifier: | NCT00541918 |
The aim of the study is to prove whether general anesthesia with inhaled sevoflurane reduces the frequency of neurological and cognitive impairment after open-heart operations with use of cardiopulmonary by-pass (CPB) in comparison with intravenous anesthesia with propofol.
Condition | Intervention | Phase |
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Heart Surgery Memory Disorders |
Drug: Diprivan (propofol, Astra Zeneca) Drug: Sevorane (sevoflurane, Abbott) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
Official Title: | COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-Heart Operations |
Estimated Enrollment: | 80 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
propofol
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Drug: Diprivan (propofol, Astra Zeneca)
TIVA with propofol
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2: Experimental
sevoflurane
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Drug: Sevorane (sevoflurane, Abbott)
inhaled anesthesia with sevoflurane
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Patients assigned to the "sevoflurane" group will be anesthetized with inhaled sevoflurane (induction and conduction of general anesthesia) and empirically administered fentanyl und pancuronium. During the CPB, sevoflurane will be delivered via the oxygenator of the CPB-machine.
Patients assigned to the "propofol" group will be anesthetized with continuous propofol infusion and empirically administered fentanyl and pancuronium.
The level of anesthesia will be monitored with BIS (bi-spectral index) - desirable level of 40 - 60.
Following preoperative data will be recorded: age, years of school education, NYHA-class, LVEF by TTE, comorbidities, glucosylated hemoglobin in patients with diabetes, non-invasive arterial blood pressure the day before the operation, smoked cigarettes, alcohol abuse.
Recorded data from operation: type of surgery, CBP duration, aortic clamp duration, duration of arterial hypotension (MAP < 60 mmHg) on CPB or SAP < 90 after CPB, the lowest perfusion gradient (MAP-CVP), the lowest pO2 in arterial blood and lowest blood oxygen saturation, lowest and average brain blood saturation (measured by INVOS), steroid dosis, aprotinin dosis, mannitol dosis on CPB, epiaortic echocardiography for aortic clamping, TEE before weaning from CPB with evaluation of deaeration of the left ventricle, highest serum glucose level, highest oesophageal temperature.
Data collected after operation: time to tracheal extubation, doses of catecholamines, consciousness disorders, CRP, S-100b protein, glucose level, core temperature, ICU stay, stay at the surgery department, hospital stay.
The patients will undergo a psychological examination four times: before the operation, before discharge from hospital (usually 4-6 days after the operation), 3 and 12 months after the operation. The psychological test for evaluating the cognitive modalities will include:
Neurological examination will be performed before and 6 days after surgery.
Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Department of Cardiac Anesthesiology, Medical University of Gdańsk | |
Gdańsk, Poland, 80-211 | |
Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery | |
Gdańsk, Poland, 80-211 |
Study Director: | Romuald Lango, M.D., Ph.D. | Medical University of Gdańsk, Department of Cardiac Anesthesiology |
Responsible Party: | Medical University of Gdańsk, Dept. of Cardiac Anesthesiology ( Romuald Lango, MD, PhD ) |
Study ID Numbers: | AMG-NKBEN/560/2006 |
Study First Received: | October 9, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00541918 |
Health Authority: | Poland: Ministry of Scientific Research and Information Technology |
sevoflurane, propofol, heart surgery, cardiopulmonary bypass, memory disorders, |
Signs and Symptoms Neurologic Manifestations Propofol |
Neurobehavioral Manifestations Memory Disorders Sevoflurane |
Anesthetics, Intravenous Nervous System Diseases Physiological Effects of Drugs Hematologic Agents Anesthetics Central Nervous System Depressants Pharmacologic Actions |
Anesthetics, Inhalation Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Central Nervous System Agents |