Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery

August 1, 2016 updated by: Dr. Horst Schmidt Klinik GmbH

Does a Sevoflurane Preconditioning Have Cardioprotective Properties in Noncardiac Thoracic Surgery?

It has been shown that the use of volatile anaesthetics, that are usually used to perform a general anesthesia, have cardioprotective properties. This has been shown in animal studies and in patients that underwent cardiac surgery. The aim of our study is to examine if Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wiesbaden, Germany, 65199
        • Dr Horst Schmidt Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lung surgery
  • ASA (American Society of Anesthesiologists) physical status 1-3

Exclusion Criteria:

  • Disposition for malignant hyperthermia
  • Medication with ß-blocking drugs
  • Use of clonidin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane
Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.
Drug: Sevoflurane
Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.
Placebo Comparator: TIVA
Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.
Drug: TIVA
Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).
Other Names:
  • Placebo
  • Controll

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Troponin T
Time Frame: change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
assessing a change in high sensitive Troponin T (5th generation) Level before and at six time points after surgery (right after surgery, every 8 hours up to 40 hours after surgery)
change of Troponin T levels preoperative and postoperative up to 40 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Horst Schmidt Klinik GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSK005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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