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

NCT00541918 | Withdrawn Phase 4

• 1 other identifier: AMG-NKBEN/560/2006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Other Functional Disturbances Following Cardiac Surgery; Memory Disorders

Keywords

sevoflurane,; propofol,; heart surgery,; cardiopulmonary bypass,; memory disorders,

Outcome Measures

Primary Outcomes (1)

• results of psychological examination

  6 days, 3 and 12 months after surgery

Secondary Outcomes (1)

• 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.

Study Arms (2)

1

ACTIVE COMPARATOR

propofol

Drug: Diprivan (propofol, Astra Zeneca)

2

EXPERIMENTAL

sevoflurane

Drug: Sevorane (sevoflurane, Abbott)

Interventions

Diprivan (propofol, Astra Zeneca) DRUG

Total intravenous anesthesia with propofol

Also known as: propofol

1

Sevorane (sevoflurane, Abbott) DRUG

inhaled anesthesia with sevoflurane

Also known as: sevoflurane

2

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults
• valve-repair open-heart surgery without coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (2)

Department of Cardiac Anesthesiology, Medical University of Gdańsk

Gdansk, 80-211, Poland

Location

Medical Universty of Gdańsk, Department of Cardiac and Vascular Surgery

Gdansk, 80-211, Poland

Location

Related Links

• Home page of the Department of Cardiac Anesthesiology, MUG.

MeSH Terms

Conditions

Memory Disorders

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Romuald Lango, M.D., Ph.D.

  Medical University of Gdańsk, Department of Cardiac Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 28, 2015

Record last verified: 2015-10

Locations

PL (2)