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 |
| Protocol serial number | 9991 |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | This is an investigator initiated and funded trial (Germany) |
- 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
Scientific
Charité - Universitätsmedizin Berlin
Charitéplatz 1
Berlin
D-10117
Germany
| Phone | +49 (0)30 450 531 012/52 |
|---|---|
| claudia.spies@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Monocentric, placebo controlled, double blind, randomised study |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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) |
| Study acronym | THORAX |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Remifentanil, clonidine and ropivacain |
| Primary outcome measure(s) |
T1/T2 ratio, measured immediately after surgery and in the first, second and third postoperative at rounds time in the morning. |
| Key secondary outcome measure(s) |
Postoperative infections, measured immediately after surgery and in the first, second and third postoperative at rounds time in the morning. |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | Lung resection |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - Universitätsmedizin Berlin
Berlin
D-10117
Germany
D-10117
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
