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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Thoracic Surgery

Treatments: Drug: Propofol; Drug: Desflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01452256

KEK-ZH Nr.2011-0092

Details and patient eligibility

About

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

Enrollment: 460 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 2 patient groups

Desflurane

Experimental group

Description:

Desflurane for pharmacological conditioning

Treatment:

Drug: Desflurane

Propofol

Experimental group

Treatment:

Drug: Propofol