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

Tracking Information

First Received Date ^ICMJE

August 18, 2011

Last Updated Date

December 3, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01452256 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Thoracic Surgery

Intervention ^ICMJE

Drug: Desflurane
4-6 Vol %
Drug: Propofol
TIVA to achieve BIS value of 40-60

Study Arm (s)

Experimental: Desflurane
Desflurane for pharmacological conditioning

Intervention: Drug: Desflurane
Experimental: Propofol
Intervention: Drug: Propofol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

486

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: 01 Studienregister MasterAdmins

+41 (0)44 255 11 11

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01452256

Other Study ID Numbers ^ICMJE

KEK-ZH Nr.2011-2092/

Has Data Monitoring Committee

Not Provided

Responsible Party

University of Zurich

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

Kantonsspital St. Gallen
Kantonsspital Münsterlingen
Universitätsspital Basel
Universitätsspital Bern

Investigators ^ICMJE

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

Information Provided By

University of Zurich

Verification Date

November 2012

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

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