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

This study has suspended participant recruitment.
(study suspended due to staff indisposition)
Sponsor:
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT00541918
First received: October 9, 2007
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Heart Surgery
Memory Disorders
Drug: Diprivan (propofol, Astra Zeneca)
Drug: Sevorane (sevoflurane, Abbott)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: COGNITIVE - Comparison of Cognitive Function After Sevoflurane or Propofol Anesthesia for Open-Heart Operations

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • results of psychological examination [ Time Frame: 6 days, 3 and 12 months after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • S-100B protein level in serum. NEECHAM delirium scale, stroke or other severe neurological impairment [ Time Frame: S-100B - 18 hours after surgery; Consciousnessand/or neurological impairment - wthin 6 days after surgery. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: June 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
propofol
Drug: Diprivan (propofol, Astra Zeneca)
TIVA with propofol
Other Name: propofol
Experimental: 2
sevoflurane
Drug: Sevorane (sevoflurane, Abbott)
inhaled anesthesia with sevoflurane
Other Name: sevoflurane

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541918

Locations
Poland
Department of Cardiac Anesthesiology, Medical University of Gdańsk
Gdańsk, Poland, 80-211
Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery
Gdańsk, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
Investigators
Study Director: Romuald Lango, M.D., Ph.D. Medical University of Gdańsk, Department of Cardiac Anesthesiology
  More Information

No publications provided

Responsible Party: Romuald Lango, MD, PhD, Medical University of Gdańsk, Dept. of Cardiac Anesthesiology
ClinicalTrials.gov Identifier: NCT00541918     History of Changes
Other Study ID Numbers: AMG-NKBEN/560/2006
Study First Received: October 9, 2007
Last Updated: October 14, 2008
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Gdansk:
sevoflurane,
propofol,
heart surgery,
cardiopulmonary bypass,
memory disorders,

Additional relevant MeSH terms:
Memory Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Propofol
Sevoflurane
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014