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

October 27, 2015 updated by: Maciej M. Kowalik, Medical University of Gdansk

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland, 80-211
        • Department of Cardiac Anesthesiology, Medical University of Gdańsk
      • Gdańsk, Poland, 80-211
        • Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
propofol
Drug: Diprivan (propofol, Astra Zeneca)
Total intravenous anesthesia with propofol
Other Names:
  • propofol
Experimental: 2
sevoflurane
Drug: Sevorane (sevoflurane, Abbott)
inhaled anesthesia with sevoflurane
Other Names:
  • sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
results of psychological examination
Time Frame: 6 days, 3 and 12 months after surgery
6 days, 3 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
S-100B - 18 hours after surgery; Consciousness and/or neurological impairment - within 6 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Study Director: Romuald Lango, M.D., Ph.D., Medical University of Gdańsk, Department of Cardiac Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 10, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMG-NKBEN/560/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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