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CompletedNCT01452256Updated Feb 17, 2016

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

A Phase 4 interventional study of Desflurane and Propofol in Thoracic Surgery, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-17.

Sponsored by University of Zurich · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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
02

Conditions studied

  • Thoracic Surgery
03

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 131 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (actual)

Study arms

  • Experimental
    Desflurane

    Desflurane for pharmacological conditioning

    Drug: Desflurane

  • Experimental
    Propofol

    Drug: Propofol

Interventions

06

What researchers measure

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

    Time frame: postoperative phase until discharge; 6 month after surgery

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • University Hospital Zurich
    Zurich, Switzerland
08

References and documents

Publications

  • 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. PubMed 34132704 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01452256
Collaborators
Cantonal Hospital of St. Gallen, Kantonsspital Münsterlingen, University Hospital, Basel, Switzerland, Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Oct 14, 2011
Start date
Dec 2011
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 17, 2016

Study contacts

01 Studienregister MasterAdmins
study director · UniversitaetsSpital Zuerich
Beatrice Beck Schimmer, Professor
principal investigator · University Hospital Zurich, Division of Anaesthesiology
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Desflurane · Propofol

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