Condition category
Surgery
Date applied
21/03/2007
Date assigned
02/08/2007
Last edited
20/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.charite.de/ch/anaest/

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

Publication citations

Additional files

Editorial Notes