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

Phase 4

Completed

• Conditions: Pulmonary Resection
• Interventions: Drug: propofol; Drug: Sevoflurane

• Registration Number: NCT02168751
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-19
• Study Start: 2012-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-20
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Anesthesiology Department Hospital GU Gregorio Mrañón; 🇪🇸 Madrid, Spain