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OpenTrials
Completed

NCT Number: NCT01452256

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

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

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Key information

Conditions

Thoracic Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

4-6 Vol %

Propofol

Drug

TIVA to achieve BIS value of 40-60

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 14, 2011
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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