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

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 |
- 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 ]
- 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 ]

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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 |
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

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