Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery
This study has been completed.
Sponsor:
University of Zurich
Collaborators:
Cantonal Hospital of St. Gallen
Kantonsspital Münsterlingen
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01452256
First received: August 18, 2011
Last updated: February 16, 2016
Last verified: February 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Thoracic Surgery |
Drug: Desflurane Drug: Propofol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Desflurane and Its Effect on Postoperative Morbidity and Mortality in Patients Undergoing Thoracic Surgery |
Resource links provided by NLM:
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 460 |
| Study Start Date: | December 2011 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Desflurane
Desflurane for pharmacological conditioning
|
Drug: Desflurane
4-6 Vol %
|
| Experimental: Propofol |
Drug: Propofol
TIVA to achieve BIS value of 40-60
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01452256
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452256
Locations
| Switzerland | |
| University Hospital Zurich | |
| Zurich, Switzerland | |
Sponsors and Collaborators
University of Zurich
Cantonal Hospital of St. Gallen
Kantonsspital Münsterlingen
University Hospital, Basel, Switzerland
University Hospital Inselspital, Berne
Investigators
| Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
| Principal Investigator: | Beatrice Beck Schimmer, Professor | University Hospital Zurich, Division of Anaesthesiology |
More Information
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01452256 History of Changes |
| Other Study ID Numbers: | KEK-ZH Nr.2011-0092 |
| Study First Received: | August 18, 2011 |
| Last Updated: | February 16, 2016 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Propofol Desflurane Isoflurane Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on September 23, 2016