- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02217319
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
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Wiesbaden, Germany, 65199
- Dr Horst Schmidt Klinik
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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.
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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.
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Placebo Comparator: TIVA
Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.
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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:
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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
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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)
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change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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