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Clinical Trials/NCT00541918
NCT00541918
Withdrawn
Phase 4

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

Medical University of Gdansk2 sites in 1 countryJune 2007

Overview

Phase
Phase 4
Intervention
Diprivan (propofol, Astra Zeneca)
Conditions
Other Functional Disturbances Following Cardiac Surgery
Sponsor
Medical University of Gdansk
Locations
2
Primary Endpoint
results of psychological examination
Status
Withdrawn
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maciej M. Kowalik

Dr.

Medical University of Gdansk

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

1

propofol

Intervention: Diprivan (propofol, Astra Zeneca)

2

sevoflurane

Intervention: Sevorane (sevoflurane, Abbott)

Outcomes

Primary Outcomes

results of psychological examination

Time Frame: 6 days, 3 and 12 months after surgery

Secondary Outcomes

  • S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment(S-100B - 18 hours after surgery; Consciousness and/or neurological impairment - within 6 days after surgery.)

Study Sites (2)

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