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

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ClinicalTrials.gov Identifier: NCT01452256
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : February 17, 2016
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
Kantonsspital Münsterlingen
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Thoracic Surgery Drug: Desflurane Drug: Propofol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Study Start Date : December 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Desflurane
Desflurane for pharmacological conditioning
 Drug: Desflurane
4-6 Vol %
Experimental: Propofol Drug: Propofol
TIVA to achieve BIS value of 40-60


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452256


Locations
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Switzerland
University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Cantonal Hospital of St. Gallen
Kantonsspital Münsterlingen
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
Investigators
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Beatrice Beck Schimmer, Professor University Hospital Zurich, Division of Anaesthesiology
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01452256    
Other Study ID Numbers: KEK-ZH Nr.2011-0092
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Propofol
Desflurane
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation