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COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541918
Recruitment Status : Withdrawn (study suspended due to staff indisposition)
First Posted : October 10, 2007
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):
Maciej M. Kowalik, Medical University of Gdansk

Brief Summary:
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 or disease Intervention/treatment Phase
Other Functional Disturbances Following Cardiac Surgery Memory Disorders Drug: Diprivan (propofol, Astra Zeneca) Drug: Sevorane (sevoflurane, Abbott) Phase 4

Detailed Description:

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:

  1. verbal learning - the Rey's AVLT test
  2. direct verbal memory - number repeating attempt from the WAIS-R/PL test
  3. direct nonverbal memory - Memory Test of Geometric Figures by Benton
  4. operating memory test - TMT test
  5. the cognitive interference test - a modified Stroop test
  6. verbal fluence - according to the Boston Test of Aphasia
  7. concentration and work effectiveness - by the Number Symbol test by Wechsler.
  8. mood - Beck's depression scale
  9. NEECHAM Delirium Scale - during the first 24-36 hours after surgery
  10. the Gough's Adjective Test will be performed with in-house relatives of the patient for evaluation the eventual emotional and eventual personality changes

Neurological examination will be performed before and 6 days after surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
Study Start Date : June 2007
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: Diprivan (propofol, Astra Zeneca)
Total intravenous anesthesia with propofol
Other Name: propofol

Experimental: 2
Drug: Sevorane (sevoflurane, Abbott)
inhaled anesthesia with sevoflurane
Other Name: sevoflurane

Primary Outcome Measures :
  1. results of psychological examination [ Time Frame: 6 days, 3 and 12 months after surgery ]

Secondary Outcome Measures :
  1. S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment [ Time Frame: S-100B - 18 hours after surgery; Consciousness and/or neurological impairment - within 6 days after surgery. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adults
  • valve-repair open-heart surgery without coronary artery bypass grafting

Exclusion Criteria:

  • active infective endocarditis
  • previous cardiac surgery
  • emergency operations
  • chronic renal failure (serum creatinine > 2,0 mg/dL)
  • left ventricle ejection fraction < 30%
  • myocardial infarction within last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00541918

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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
Sponsors and Collaborators
Medical University of Gdansk
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Study Director: Romuald Lango, M.D., Ph.D. Medical University of Gdańsk, Department of Cardiac Anesthesiology
Additional Information:
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Responsible Party: Maciej M. Kowalik, Dr., Medical University of Gdansk Identifier: NCT00541918    
Other Study ID Numbers: AMG-NKBEN/560/2006
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Maciej M. Kowalik, Medical University of Gdansk:
heart surgery,
cardiopulmonary bypass,
memory disorders,
Additional relevant MeSH terms:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation