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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02168751
Enrollment
180
Registered
2014-06-20
Start date
2012-09-30
Completion date
2014-06-30
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Resection

Keywords

one lung ventilation, inflammatory response, thoracic surgery

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.

Interventions

DRUGpropofol
DRUGSevoflurane

Sponsors

Ministry of Health, Spain
CollaboratorOTHER_GOV
Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in inflammation markers in plasma and bronchoalveolar lavagebaseline and 5 minutesFiberoptic 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026