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

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ClinicalTrials.gov Identifier: NCT02168751
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pulmonary Resection Drug: propofol Drug: Sevoflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in inflammation markers in plasma and bronchoalveolar lavage [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168751


Locations
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Spain
Anesthesiology Department Hospital GU Gregorio Mrañón
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Ministry of Health, Spain
Investigators
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Principal Investigator: Francisco de la Gala, PhD Hospital General Universitario Gregorio Marañón

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02168751     History of Changes
Other Study ID Numbers: FIBHGM-ECNC003-2011
2011-002294-29 ( EudraCT Number )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by Hospital General Universitario Gregorio Marañon:
one lung ventilation
inflammatory response
thoracic surgery
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation