Clinical trial NCT02168751: Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents
Official title: STUDY OF PULMONARY AND SYSTEMIC INFLAMMATORY RESPONSE SECONDARY TO LUNG RESECTION SURGERY USING INTRAVENOUS ANESTHESIA VERSUS INHALATION ANESTHESIA WITH HALOGENATED AGENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Resection
Keywords: one lung ventilation
inflammatory response
thoracic surgery
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
First posted: 2014-06-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* candidates to Lung resection surgery at Hospital General Universitario Gregorio Marañón (males and females)
* willing to participate and sign informed consent
* age \> 18 años and legal capable
* no urgent surgery.
* FEV1 \>50% or CVF \> 50%
* no previous steroids or immunosuppressors chronic treatment (three months before the surgery)

Exclusion Criteria:

* pregnancy and breast feeding
* propofol or sevoflurane hypersensibility.
* have received blood derivate product within 10 days before surgery.
* when protective pulmonary ventilation is not possible during one Lung ventilation.
* Heart failure \> II NYHA within one week before surgery

Primary outcomes:
measure: Change in inflammation markers in plasma and bronchoalveolar lavage
timeFrame: baseline and 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Anesthesiology Department Hospital GU Gregorio Mrañón
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Francisco de la Gala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.