Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00484575
First received: June 8, 2007
Last updated: May 19, 2010
Last verified: June 2007
  Purpose

Inhaled sevoflurane during coronary artery bypass grafting (CABG) reduces postoperative Troponin levels and may be associated with improved outcome. A dose-response effect has been demonstrated by de Hert et al, with greatest reductions of Troponin when Sevoflurane was used during the entire operation, as compared to Sevoflurane during parts of the operation.

Sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. Postoperative sedation after CABG is currently achieved with intravenous propofol.

A new simplified method of administration of isoflurane or sevoflurane has been developed and tested by members of the research group. The Anesthetic Conserving Device is a modified heat-moisture exchanger (HME) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device.

The primary aim (and primary hypothesis)of the current trial is to examine if postoperative sedation with sevoflurane after CABG is associated with improved cardiac outcome, measured as reduced levels of Troponin, BNP and reduced incidence of cardiac events, such as atrial fibrillation, need for inotropic drugs and myocardial infarction, compared with conventional propofol sedation.

Other end-points of the trial are potential renal (protective) effects measured with cystatin C levels, need for dialysis but also measurements of inorganic fluorides in serum, as well as environmental aspects of sevoflurane sedation in a Cardiothoracic Intensive Care Unit. Furthermore, potential differences in ICU memories and well-being during stay in the intensive Care Unit will be investigated via patient questionnaires.

Besides routine blood sampling, plasma will be saved for later analysis of inflammatory mediators (biobank).


Condition Intervention Phase
Myocardial Reperfusion Injury
Atrial Fibrillation
Drug: Sevoflurane
Drug: propofol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Troponin levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • renal function [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • ambient sevoflurane levels [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
  • cognitive function/memory panorama post ICU [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • attenuation of inflammatory response [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol
propofol for sedation minimum 2 hours in CTICU after CABG
Drug: propofol
propofol given intravenously for sedation in control group
Other Name: Propofol
Experimental: sevoflurane
Sevoflurane via AnaConDa for minimum 2 hours in CTICU after CABG
Drug: Sevoflurane
given by infusion via AnaConDa for sedation with target MAAS 2-3
Other Name: Sevorane

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned coronary artery bypass grafting

Exclusion Criteria:

  • Combined heart valve surgery
  • Malignant Hyperthermia
  • Postoperative need for mechanical circulation support
  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: NCT00484575

Locations
Sweden
Karolinska University Hospital Solna, Cardiothoracic Intensive Care Unit
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Peter V Sackey, MD, PhD Karolinska Institutet, Institution of Physiology and Pharmacology, Section for Anesthesia and Intensive Care Medicine
Principal Investigator: Jan-Olof Hellström, MD Karolinska Institutet, Institution of Physiology and Phrmacology, Section for Anesthesia and Intensive Care
Principal Investigator: Anders Öwall, MD, PhD Karolinska University Solna, Department of Cardiothoracic Anesthesia and Intensive Care
  More Information

No publications provided

Responsible Party: Peter Sackey, MD, PhD, Dept of Physiology and Pharmacology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00484575     History of Changes
Other Study ID Numbers: 2007-000293-23
Study First Received: June 8, 2007
Last Updated: May 19, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Sevoflurane
CABG
cardioprotection
AnaConDa

Additional relevant MeSH terms:
Atrial Fibrillation
Myocardial Reperfusion Injury
Reperfusion Injury
Wounds and Injuries
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiomyopathies
Myocardial Ischemia
Vascular Diseases
Postoperative Complications
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on August 18, 2014