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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002294-29 | EudraCT Number |
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| Name | Class |
|---|---|
| Ministry of Health, Spain | OTHER_GOV |
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Lung ventilation required for lung resection surgery induces a proinflammatory response including cytokine production and recruitment of leukocytes and macrophages in the lung associated with postoperative complications, mainly acute lung injury (ALI). The lung-protective ventilation has been shown reduce this inflammatory response and play a protective role against ALI, even though it is unclear the role of intravenous and inhalational anesthetic agents in immunomodulation of the inflammatory response during lung ventilation and its possible protective role against ALI. This study aims to determine the effect of anesthetic agents on markers of lung inflammation, the mechanisms of oxidative stress and ischemia-reperfusion, and assess the relationship between these mediators and postoperative morbidity defined as percentage of postoperative lung complications (ALI / ARDS, pneumonia and atelectasis), length of stay in ICU, hospital stay and mortality at 30 days. The investigators hypothesis, based on results of our group in animal research, is that inhalants cause a lower proinflammatory response to intravenous agents for lung resection surgery.
A clinical trial is design with two groups (propofol, sevoflurane) managed all with lung protective ventilation, in which the markers will be measured before and after one-lung ventilation in both lungs and in plasma before, during and after one-lung ventilation. postoperative lung complications, ICU and hospital stay and 30 days mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol | Active Comparator | propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery |
|
| sevoflurane | Experimental | Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug |
| ||
| Sevoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammation markers in plasma and bronchoalveolar lavage | Fiberoptic bronchoalveolar lavage (BAL) performed in both lungs at two moments: Baseline ( 5 minutes before the begining of OLV) and at the end of the OLV ( 5 minutes after the two lung vetilation was restored). | baseline and 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco de la Gala, PhD | Hospital General Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesiology Department Hospital GU Gregorio Mrañón | Madrid | Madrid | 28007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38155459 | Derived | Alonso A, de la Gala F, Vara E, Hortal J, Pineiro P, Reyes A, Simon C, Garutti I. Lung and blood perioperative metalloproteinases in patients undergoing oncologic lung surgery: Prognostic implications. Thorac Cancer. 2024 Feb;15(4):307-315. doi: 10.1111/1759-7714.15190. Epub 2023 Dec 28. | |
| 30656507 | Derived |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Garutti I, De la Gala F, Pineiro P, Rancan L, Vara E, Reyes A, Puente-Maestu L, Bellon JM, Simon C. Usefulness of combining clinical and biochemical parameters for prediction of postoperative pulmonary complications after lung resection surgery. J Clin Monit Comput. 2019 Dec;33(6):1043-1054. doi: 10.1007/s10877-019-00257-4. Epub 2019 Jan 17. |
| 29121283 | Derived | de la Gala F, Pineiro P, Reyes A, Vara E, Olmedilla L, Cruz P, Garutti I. Postoperative pulmonary complications, pulmonary and systemic inflammatory responses after lung resection surgery with prolonged one-lung ventilation. Randomized controlled trial comparing intravenous and inhalational anaesthesia. Br J Anaesth. 2017 Oct 1;119(4):655-663. doi: 10.1093/bja/aex230. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |