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

NCT01452256 | Completed Phase 4

• 1 other identifier: KEK-ZH Nr.2011-0092
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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)

  postoperative phase until discharge

Study Arms (2)

Desflurane

EXPERIMENTAL

Desflurane for pharmacological conditioning

Drug: Desflurane

Propofol

EXPERIMENTAL

Drug: Propofol

Interventions

Desflurane DRUG

4-6 Vol %

Desflurane

Propofol DRUG

TIVA to achieve BIS value of 40-60

Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lung resection
• One-lung ventilation
• Adults (18-80 years of age)
• ASA classification I - III
• Written consent (signature from patient)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Cantonal Hospital of St. Gallen: collaborator
• Kantonsspital Münsterlingen: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34132704 DERIVED

MeSH Terms

Interventions

Desflurane; Propofol

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

• Beatrice Beck Schimmer, Professor

  University Hospital Zurich, Division of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: October 14, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

CH (1)