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

Memory Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00541918
• Other study ID #: AMG-NKBEN/560/2006
• Status: Withdrawn
• Phase: Phase 4
• First received: October 9, 2007
• Last updated: October 27, 2015
• Start date: June 2007
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Memory Disorders
• Other Functional Disturbances Following Cardiac Surgery
• Pathologic Processes

Intervention

Drug:
• Diprivan (propofol, Astra Zeneca)
Total intravenous anesthesia with propofol
• Sevorane (sevoflurane, Abbott)
inhaled anesthesia with sevoflurane

Locations

Country	Name	City	State
Poland	Department of Cardiac Anesthesiology, Medical University of Gdansk	Gdansk
Poland	Medical Universty of Gdansk, Department of Cardiac and Vascular Surgery	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	results of psychological examination		6 days, 3 and 12 months after surgery	Yes
Secondary	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.	Yes