Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents

Hospital General Universitario Gregorio Marañon

Status and phase

Completed

Phase 4

Conditions

Pulmonary Resection

Treatments

Drug: Sevoflurane

Drug: propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT02168751

2011-002294-29 (EudraCT Number)

FIBHGM-ECNC003-2011

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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