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

Information source: University of Zurich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thoracic Surgery

Intervention: Desflurane (Drug); Propofol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Zurich

Official(s) and/or principal investigator(s):
01 Studienregister MasterAdmins, Study Director, Affiliation: UniversitaetsSpital Zuerich
Beatrice Beck Schimmer, Professor, Principal Investigator, Affiliation: University Hospital Zurich, Division of Anaesthesiology

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

Clinical Details

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

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

Primary outcome: 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

Secondary outcome:

Major complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. after dimissio up to 6 months after surgery

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)

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

University Hospital Zurich, Zurich, Switzerland
Additional Information

Starting date: December 2011
Last updated: March 4, 2015

Page last updated: August 23, 2015

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