The effects of selective neurogenic blockades on the perioperative immune reaction of patients undergoing lung resection (Pilotstudie zum einfluss selektiver neurogener blockaden auf die perioperative immunreaktion bei lungen-resezierten patienten)

ISRCTN ISRCTN47414487
DOI https://doi.org/10.1186/ISRCTN47414487
Secondary identifying numbers 9991
Submission date
21/03/2007
Registration date
02/08/2007
Last edited
01/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Charité - Universitätsmedizin Berlin
Charitéplatz 1
Berlin
D-10117
Germany

Phone +49 (0)30 450 531 012/52
Email claudia.spies@charite.de

Study information

Study designMonocentric, placebo controlled, double blind, randomised study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effects of selective neurogenic blockades on the perioperative immune reaction of patients undergoing lung resection (Pilotstudie zum einfluss selektiver neurogener blockaden auf die perioperative immunreaktion bei lungen-resezierten patienten)
Study acronymTHORAX
Study objectivesThe 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(s)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).
Health condition(s) or problem(s) studiedLung resection
InterventionThere 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Remifentanil, clonidine and ropivacain
Primary outcome measureT1/T2 ratio, measured immediately after surgery and in the first, second and third postoperative at rounds time in the morning.
Secondary outcome measuresPostoperative infections, measured immediately after surgery and in the first, second and third postoperative at rounds time in the morning.
Overall study start date01/01/2006
Completion date01/07/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants60
Total final enrolment60
Key inclusion criteriaLung resection
Key exclusion criteria1. 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
Date of first enrolment01/01/2006
Date of final enrolment01/07/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité - Universitätsmedizin Berlin
Berlin
D-10117
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Charitéplatz 1
Berlin
D-10117
Germany

Phone +49 (0)30 450 531 012/52
Email claudia.spies@charite.de
Website http://www.charite.de/ch/anaest/
ROR logo "ROR" https://ror.org/001w7jn25

Funders

Funder type

Other

This is an investigator initiated and funded trial (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/02/2012 01/09/2021 Yes No

Editorial Notes

01/09/2021: Publication reference and total final enrolment added.