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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:
Kantonsspital 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
History of Changes
  Purpose

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

Condition Intervention Phase
Thoracic Surgery
 Drug: Desflurane
Drug: Propofol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 486
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desflurane
Desflurane for pharmacological conditioning
 Drug: Desflurane
4-6 Vol %
Experimental: Propofol Drug: Propofol
TIVA to achieve BIS value of 40-60

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452256

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Kantonsspital St. Gallen
Kantonsspital Münsterlingen
Universitätsspital Basel
Universitätsspital Bern
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Beatrice Beck Schimmer, Professor University Hospital Zurich, Division of Anaesthesiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01452256     History of Changes
Other Study ID Numbers: KEK-ZH Nr.2011-2092/
Study First Received: August 18, 2011
Last Updated: December 3, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Propofol
Desflurane
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on June 18, 2013