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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452256
• Other study ID #: KEK-ZH Nr.2011-0092
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2011
• Last updated: February 16, 2016
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Drug:
• Desflurane
4-6 Vol %
• Propofol
TIVA to achieve BIS value of 40-60

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (5)

Lead Sponsor	Collaborator
University of Zurich	Cantonal Hospital of St. Gallen, Kantonsspital Münsterlingen, University Hospital Inselspital, Berne, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Perioperative inflammatory mediators TNF-a, 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	No