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

Pulmonary Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168751
• Other study ID #: FIBHGM-ECNC003-2011
• Secondary ID: 2011-002294-29
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2012
• Last updated: April 4, 2016
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Resection

Intervention

Drug:
• propofol

• Sevoflurane

Locations

Country	Name	City	State
Spain	Anesthesiology Department Hospital GU Gregorio Mrañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline and 5 minutes	No