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

NCT ID: NCT00541918

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2015-04-30

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.

Conditions

Other Functional Disturbances Following Cardiac Surgery; Memory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

propofol

Group Type: ACTIVE_COMPARATOR

Diprivan (propofol, Astra Zeneca)

Intervention Type: DRUG

Total intravenous anesthesia with propofol

2

sevoflurane

Group Type: EXPERIMENTAL

Sevorane (sevoflurane, Abbott)

Intervention Type: DRUG

inhaled anesthesia with sevoflurane

Interventions

Diprivan (propofol, Astra Zeneca)

Total intravenous anesthesia with propofol

Intervention Type: DRUG

Sevorane (sevoflurane, Abbott)

inhaled anesthesia with sevoflurane

Intervention Type: DRUG

Other Intervention Names

propofol; sevoflurane

Eligibility 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 infarction within last 30 days

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Gdansk

OTHER

Sponsor Role: lead

Responsible Party

Maciej M. Kowalik

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romuald Lango, M.D., Ph.D.

Role: STUDY_DIRECTOR

Medical University of Gdańsk, Department of Cardiac Anesthesiology

Locations

Department of Cardiac Anesthesiology, Medical University of Gdańsk

Gdansk, , Poland

Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery

Gdansk, , Poland

Countries

Poland

Related Links

http://www.amg.gda.pl/uczelnia/informator/jednostka.php?id=327

Home page of the Department of Cardiac Anesthesiology, MUG.

Other Identifiers

AMG-NKBEN/560/2006

Identifier Type: -

Identifier Source: org_study_id