Clinical trial NCT01452256: Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Official title: Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracic Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of St. Gallen
name: Kantonsspital Münsterlingen
name: University Hospital, Basel, Switzerland
name: Insel Gruppe AG, University Hospital Bern
First posted: 2011-10-14
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: postoperative phase until discharge; 6 month after surgery
Secondary outcomes:
measure: Major complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. after dimissio up to 6 months after surgery
timeFrame: postoperative phase until discharge, 6 month postoperative
measure: 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)
timeFrame: postoperative phase until discharge
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Anaesthesiology
name: Beatrice Beck Schimmer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neff TA, Braun J, Rana D, Puhan M, Filipovic M, Seeberger M, Stuber F, Neff SB, Beck-Schimmer B, Schlapfer M. Interleukin-6 Is an Early Plasma Marker of Severe Postoperative Complications in Thoracic Surgery: Exploratory Results From a Substudy of a Randomized Controlled Multicenter Trial. Anesth Analg. 2022 Jan 1;134(1):123-132. doi: 10.1213/ANE.0000000000005639.