Back to resultsCardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery
Primary Purpose
High Sensitive Troponin T Release
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Sevoflurane
TIVA
Sponsored by
About this trial
This is an interventional prevention trial for High Sensitive Troponin T Release focused on measuring Volatile Anesthetic, Cardioprotection, Lung surgery, non cardiac surgery
Eligibility Criteria
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
Sites / Locations
- Dr Horst Schmidt Klinik
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sevoflurane
TIVA
Arm Description
Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.
Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.
Outcomes
Primary Outcome Measures
Troponin T
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02217319
First Posted
August 8, 2014
Last Updated
August 1, 2016
Sponsor
Dr. Horst Schmidt Klinik GmbH
1. Study Identification
Unique Protocol Identification Number
NCT02217319
Brief Title
Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery
Official Title
Does a Sevoflurane Preconditioning Have Cardioprotective Properties in Noncardiac Thoracic Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Sensitive Troponin T Release
Keywords
Volatile Anesthetic, Cardioprotection, Lung surgery, non cardiac surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Description
Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.
Arm Title
TIVA
Arm Type
Placebo Comparator
Arm Description
Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TIVA
Other Intervention Name(s)
Placebo, Controll
Intervention Description
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).
Primary Outcome Measure Information:
Title
Troponin T
Description
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)
Time Frame
change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dr Horst Schmidt Klinik
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery
We'll reach out to this number within 24 hrs