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

Sponsor

Hospital General Universitario Gregorio Marañon (Other)

Overall Status

Completed

CT.gov ID

NCT02168751

Collaborator

Ministry of Health, Spain (Other)

180

Enrollment

Location

Arms

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Resection	Drug: propofol Drug: Sevoflurane	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

STUDY OF PULMONARY AND SYSTEMIC INFLAMMATORY RESPONSE SECONDARY TO LUNG RESECTION SURGERY USING INTRAVENOUS ANESTHESIA VERSUS INHALATION ANESTHESIA WITH HALOGENATED AGENTS

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: propofol propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery	Drug: propofol
Experimental: sevoflurane Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery	Drug: Sevoflurane

Arm

Intervention/Treatment

Active Comparator: propofol

propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery

Drug: propofol

Experimental: sevoflurane

Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery

Drug: Sevoflurane

Outcome Measures

Primary Outcome Measures

Change in inflammation markers in plasma and bronchoalveolar lavage [baseline and 5 minutes]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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