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

Study Overview
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Brief Summary
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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

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

Conditions
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Thoracic Surgery

Intervention / Treatment
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* Drug: Desflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desflurane<br>Desflurane for pharmacological conditioning | Drug: Desflurane<br>* 4-6 Vol %<br>|
| Experimental: Propofol<br> | Drug: Propofol<br>* TIVA to achieve BIS value of 40-60<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | postoperative phase until discharge; 6 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. after dimissio up to 6 months after surgery |  | 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) |  | postoperative phase until discharge |