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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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propofol

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

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

sevoflurane

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Interventions

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propofol

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No