Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents
Primary Purpose
Pulmonary Resection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
propofol
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Resection focused on measuring one lung ventilation, inflammatory response, thoracic surgery
Eligibility 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
Sites / Locations
- Anesthesiology Department Hospital GU Gregorio Mrañón
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
propofol
sevoflurane
Arm Description
propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery
Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery
Outcomes
Primary Outcome Measures
Change in inflammation markers in plasma and bronchoalveolar lavage
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02168751
First Posted
July 19, 2012
Last Updated
April 4, 2016
Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
Ministry of Health, Spain
1. Study Identification
Unique Protocol Identification Number
NCT02168751
Brief Title
Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents
Official Title
STUDY OF PULMONARY AND SYSTEMIC INFLAMMATORY RESPONSE SECONDARY TO LUNG RESECTION SURGERY USING INTRAVENOUS ANESTHESIA VERSUS INHALATION ANESTHESIA WITH HALOGENATED AGENTS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Universitario Gregorio Marañon
Collaborators
Ministry of Health, Spain
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Resection
Keywords
one lung ventilation, inflammatory response, thoracic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery
Arm Title
sevoflurane
Arm Type
Experimental
Arm Description
Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Primary Outcome Measure Information:
Title
Change in inflammation markers in plasma and bronchoalveolar lavage
Description
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).
Time Frame
baseline and 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco de la Gala, PhD
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology Department Hospital GU Gregorio Mrañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
30656507
Citation
Garutti I, De la Gala F, Pineiro P, Rancan L, Vara E, Reyes A, Puente-Maestu L, Bellon JM, Simon C. Usefulness of combining clinical and biochemical parameters for prediction of postoperative pulmonary complications after lung resection surgery. J Clin Monit Comput. 2019 Dec;33(6):1043-1054. doi: 10.1007/s10877-019-00257-4. Epub 2019 Jan 17.
Results Reference
derived
PubMed Identifier
29121283
Citation
de la Gala F, Pineiro P, Reyes A, Vara E, Olmedilla L, Cruz P, Garutti I. Postoperative pulmonary complications, pulmonary and systemic inflammatory responses after lung resection surgery with prolonged one-lung ventilation. Randomized controlled trial comparing intravenous and inhalational anaesthesia. Br J Anaesth. 2017 Oct 1;119(4):655-663. doi: 10.1093/bja/aex230.
Results Reference
derived
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Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents
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