Inhaled Sevoflurane Compared to Intravenous Sedation Post Coronary Artery Bypass Grafting

NCT00484575 | Completed Phase 1

• 1 other identifier: 2007-000293-23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Myocardial Reperfusion Injury; Atrial Fibrillation

Keywords

Sevoflurane; CABG; cardioprotection; AnaConDa

Outcome Measures

Primary Outcomes (1)

• Troponin levels

  2 days

Secondary Outcomes (4)

• renal function

  1 week

• ambient sevoflurane levels

  2 days

• cognitive function/memory panorama post ICU

  1 week

• attenuation of inflammatory response

  2 days

Study Arms (2)

propofol

ACTIVE COMPARATOR

propofol for sedation minimum 2 hours in CTICU after CABG

Drug: propofol

sevoflurane

EXPERIMENTAL

Sevoflurane via AnaConDa for minimum 2 hours in CTICU after CABG

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

given by infusion via AnaConDa for sedation with target MAAS 2-3

Also known as: Sevorane

sevoflurane

propofol DRUG

propofol given intravenously for sedation in control group

propofol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned coronary artery bypass grafting

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital Solna, Cardiothoracic Intensive Care Unit

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Myocardial Reperfusion Injury; Atrial Fibrillation

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac

Intervention Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 20, 2010

Record last verified: 2007-06

Locations

SE (1)