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

This study has been completed.

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

ClinicalTrials.gov Identifier:

NCT01452256

First received: August 18, 2011

Last updated: February 16, 2016

Last verified: February 2016

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 Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery

Resource links provided by NLM:

Drug Information available for: Propofol Desflurane

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 ]

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 ]
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 ]


Enrollment:	460
Study Start Date:	December 2011
Study Completion Date:	December 2014
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 (Adult, Senior)
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

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: NCT01452256

Locations


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


Study Director:	01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich
Principal Investigator:	Beatrice Beck Schimmer, Professor	University Hospital Zurich, Division of Anaesthesiology

More Information


Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT01452256 History of Changes
Other Study ID Numbers:	KEK-ZH Nr.2011-0092
Study First Received:	August 18, 2011
Last Updated:	February 16, 2016

Additional relevant MeSH terms:


Propofol Desflurane Isoflurane Hypnotics and Sedatives Central Nervous System Depressants	Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics Anesthetics, Inhalation

ClinicalTrials.gov processed this record on June 23, 2017

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