Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery

This study is currently recruiting participants.
Verified November 2012 by University of Zurich
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
Kantonsspital Münsterlingen
Universitätsspital Basel
Universitätsspital Bern
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01452256
First received: August 18, 2011
Last updated: December 3, 2012
Last verified: November 2012

August 18, 2011
December 3, 2012
December 2011
December 2014   (final data collection date for primary outcome measure)
Major complications as defined as ≥ grade IIIa according to classification of surgical complications from Dindo et al. after lung resection with one-lung ventilation during hospitalization [ Time Frame: postoperative phase until discharge; 6 month after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01452256 on ClinicalTrials.gov Archive Site
  • Major complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. after dimissio up to 6 months after surgery [ Time Frame: postoperative phase until discharge, 6 month postoperative ] [ Designated as safety issue: No ]
  • Perioperative inflammatory mediators TNF-α, IL-6, IL-8, sICAM-1, MCP-1, MIP-2 in blood (correlation to complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. during hospitalization) [ Time Frame: postoperative phase until discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Not Provided

Desflurane and its effect on postoperative morbidity and mortality in patients undergoing thoracic surgery.

Halothane, enflurane, isoflurane, sevoflurane, and desflurane are volatile anesthetics, a group of general anesthetics. Because of the hypnotic effects of these agents, attention has mainly focused on the central nervous system. In the last 10 years, however, numerous studies have reported that volatile anesthetic agents interact with membrane structures of the myocardium and thereby attenuate cardiac mechanical dysfunction and limit ultrastructural abnormality on reperfusion after prolonged ischemia in the myocyte. Anesthetic-induced preconditioning has become a main topic in cardiac research worldwide

  • Trial with medicinal product
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic Surgery
  • Drug: Desflurane
    4-6 Vol %
  • Drug: Propofol
    TIVA to achieve BIS value of 40-60
  • Experimental: Desflurane
    Desflurane for pharmacological conditioning
    Intervention: Drug: Desflurane
  • Experimental: Propofol
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
486
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion criteria: • Elective thoracic surgery (thoracotomy, thoracoscopy)

  • Lung resection
  • One-lung ventilation
  • Adults (18-80 years of age)
  • ASA classification I - III
  • Written consent (signature from patient)

Exclusion criteria:

  • Known hypersensitivity or suspected allergy to propofol, soja or egg proteins
  • Known hypersensitivity to volatile anesthetics (malignant hyperthermia)
  • Medication with high dosage of statins
  • Therapy with cyclosporin
  • Severe renal impairment (GFR < 30 ml/min)
  • Oral steroid treatment at present or stopped less than 3 months before surgery
  • Inflammatory processes (non-pulmonary or pulmonary): elevated C-reactive protein level (> 20 mg/l) or leukocytosis (leukocytes > 10x103/?l) or body temperature > 37°C)
  • Pregnancy
  • Breast feeding
  • The subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
Both
18 Years to 80 Years
No
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11
Switzerland
 
NCT01452256
KEK-ZH Nr.2011-2092/
Not Provided
University of Zurich
University of Zurich
  • Cantonal Hospital of St. Gallen
  • Kantonsspital Münsterlingen
  • Universitätsspital Basel
  • Universitätsspital Bern
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Beatrice Beck Schimmer, Professor University Hospital Zurich, Division of Anaesthesiology
University of Zurich
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP