COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
Primary Purpose
Other Functional Disturbances Following Cardiac Surgery, Memory Disorders
Status
Withdrawn
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Diprivan (propofol, Astra Zeneca)
Sevorane (sevoflurane, Abbott)
Sponsored by
About this trial
This is an interventional prevention trial for Other Functional Disturbances Following Cardiac Surgery focused on measuring sevoflurane,, propofol,, heart surgery,, cardiopulmonary bypass,, memory disorders,
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
Sites / Locations
- Department of Cardiac Anesthesiology, Medical University of Gdańsk
- Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
propofol
sevoflurane
Outcomes
Primary Outcome Measures
results of psychological examination
Secondary Outcome Measures
S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment
Full Information
NCT ID
NCT00541918
First Posted
October 9, 2007
Last Updated
October 27, 2015
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT00541918
Brief Title
COGNITIVE - Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
Official Title
COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-heart Operations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
study suspended due to staff indisposition
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
verbal learning - the Rey's AVLT test
direct verbal memory - number repeating attempt from the WAIS-R/PL test
direct nonverbal memory - Memory Test of Geometric Figures by Benton
operating memory test - TMT test
the cognitive interference test - a modified Stroop test
verbal fluence - according to the Boston Test of Aphasia
concentration and work effectiveness - by the Number Symbol test by Wechsler.
mood - Beck's depression scale
NEECHAM Delirium Scale - during the first 24-36 hours after surgery
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Functional Disturbances Following Cardiac Surgery, Memory Disorders
Keywords
sevoflurane,, propofol,, heart surgery,, cardiopulmonary bypass,, memory disorders,
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
propofol
Arm Title
2
Arm Type
Experimental
Arm Description
sevoflurane
Intervention Type
Drug
Intervention Name(s)
Diprivan (propofol, Astra Zeneca)
Other Intervention Name(s)
propofol
Intervention Description
Total intravenous anesthesia with propofol
Intervention Type
Drug
Intervention Name(s)
Sevorane (sevoflurane, Abbott)
Other Intervention Name(s)
sevoflurane
Intervention Description
inhaled anesthesia with sevoflurane
Primary Outcome Measure Information:
Title
results of psychological examination
Time Frame
6 days, 3 and 12 months after surgery
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romuald Lango, M.D., Ph.D.
Organizational Affiliation
Medical University of Gdańsk, Department of Cardiac Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiac Anesthesiology, Medical University of Gdańsk
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
12. IPD Sharing Statement
Links:
URL
http://www.amg.gda.pl/uczelnia/informator/jednostka.php?id=327
Description
Home page of the Department of Cardiac Anesthesiology, MUG.
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