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

NCT ID: NCT01452256

Last Updated: 2016-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Desflurane

Desflurane for pharmacological conditioning

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

4-6 Vol %

Propofol

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

TIVA to achieve BIS value of 40-60

Interventions

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Desflurane

4-6 Vol %

Intervention Type DRUG

Propofol

TIVA to achieve BIS value of 40-60

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role collaborator

Kantonsspital Münsterlingen

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Beatrice Beck Schimmer, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Anaesthesiology

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34132704 (View on PubMed)

Other Identifiers

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KEK-ZH Nr.2011-0092

Identifier Type: -

Identifier Source: org_study_id

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