COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-Heart Operations
Information source: Medical University of Gdansk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Surgery; Memory Disorders
Intervention: Diprivan (propofol, Astra Zeneca) (Drug); SEVORANE (sevoflurane, Abbott) (Drug)
Phase: Phase 4
Status: Suspended
Sponsored by: Medical University of Gdansk Official(s) and/or principal investigator(s):
Romuald Lango, M.D., Ph.D., Study Director, Affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology
Summary
The aim of the study is to prove if 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.
Clinical Details
Official title: COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-Heart Operations
Study design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study
Primary outcome: results of psychological examination
Secondary outcome: S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment
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 cigarets, 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
ay the surgery department, hospital stay.
The patients will undergo four times a psychological examination: 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 evaluation 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.
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 infarct within last 30 days.
Locations and Contacts
Department of Cardiac Anesthesiology, Medical University of Gdańsk, Gdańsk 80-211, Poland
Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery, Gdańsk 80-211, Poland
Additional Information
Home page of the Department of Cardiac Anesthesiology, MUG.
Starting date: June 2007
Ending date: December 2009
Last updated: May 15, 2008
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