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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01452256
Enrollment
460
Registered
2011-10-14
Start date
2011-12-31
Completion date
2014-12-31
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery

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

Interventions

DRUGDesflurane

4-6 Vol %

DRUGPropofol

TIVA to achieve BIS value of 40-60

Sponsors

Cantonal Hospital of St. Gallen
CollaboratorOTHER
Kantonsspital Münsterlingen
CollaboratorOTHER
University Hospital, Basel, Switzerland
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 hospitalizationpostoperative phase until discharge; 6 month after surgery

Secondary

MeasureTime frame
Major complications ≥ grade IIIa according to classification of surgical complications from Dindo et al. after dimissio up to 6 months after surgerypostoperative 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026