Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Charité - Universitätsmedizin Berlin
Charitéplatz 1
Berlin
D-10117
Germany
+49 (0)30 450 531 012/52
claudia.spies@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9991
Study information
Scientific title
Acronym
THORAX
Study hypothesis
The overall interest of this study is to clarify if perioperative neurogenic blockades such as:
1. Thoracic epidural block (epidural ropivacain),
2. Central sympathetic inhibition via alpha-2 receptor stimulation (intravenous [i.v.] clonidine), or
3. Inhibition of the excitatory nonadrenergic-noncholinergic neurotransmission and of the hypothalamic-pituitary-adrenal axis (i.v. remifentanil),
can, by reducing the pro-inflammatory reactions immediately after surgery, effectively stop excessive anti-inflammation and consequently avoid immunosuppression after thoracic surgery. In this way selective neurogenic blockades could, as a perioperative preventive measure, contribute to lower the postoperative infection rate.
Ethics approval
The ethics committee were informed throughout and they gave permission for the performance of this clinical trial on the 27th December 2005 (ref: Ethics code LaGeSo Berlin/Germany 2005/12/27: EA 1/175/05).
Study design
Monocentric, placebo controlled, double blind, randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lung resection
Intervention
There are three treatment arms:
1. Ropivacain
2. Remifentanil
3. Remifentanil plus Clonidin
These will be given as follows:
1. After epidural placement of the catheter 10 ml bolus ropivacain 0.75%/placebo epidural
2. After anaesthesia induction 150 µg bolus clonidin/placebo intravenous
3. Epidural syringe pump with ropivacain 0.2%/placebo 6 - 10 ml/h during surgery
4. Intravenous syringe-pump with clonidin/placebo 20 - 100 µg/h during surgery
5. Intravenous syringe-pump with remifentalil 0.2%/placebo 0.2 - 0.4 µg/kg/min during surgery
The interventional treatment is limited to the duration of surgery and therefore depends on operation time; we perform neither pre- nor post-operative interventions. The follow up period amounts to three postoperative days.
Intervention type
Drug
Phase
Not Specified
Drug names
Remifentanil, clonidine and ropivacain
Primary outcome measures
T1/T2 ratio, measured immediately after surgery and in the first, second and third postoperative at rounds time in the morning.
Secondary outcome measures
Postoperative infections, measured immediately after surgery and in the first, second and third postoperative at rounds time in the morning.
Overall trial start date
01/01/2006
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Lung resection
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Patient under age
2. Pregnancy
3. Contraindications for epidural block
4. Contraindications for ropivacain
5. Contraindications for remifantanil
6. Contraindications for clonidine
9. Treatment with local anaesthetics
10. Treatment with central anti-adrenergic drugs (clonidine, methyldopa, moxonidine, reserpine)
11. Treatment with opioids
12. Myocardial Infarction (MI) within the last eight weeks
13. Cardiac insufficiency New York Heart Association (NYHA) III and IV
Recruitment start date
01/01/2006
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Charité - Universitätsmedizin Berlin
Berlin
D-10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
Charitéplatz 1
Berlin
D-10117
Germany
+49 (0)30 450 531 012/52
claudia.spies@charite.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
This is an investigator initiated and funded trial (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary