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

NCT02168751 | Completed Phase 4

• 2 other identifiers: FIBHGM-ECNC003-20112011-002294-29
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Resection

Keywords

one lung ventilation; inflammatory response; thoracic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

propofol

ACTIVE COMPARATOR

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

Drug: propofol

sevoflurane

EXPERIMENTAL

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

Drug: Sevoflurane

Interventions

propofol DRUG

propofol

Sevoflurane DRUG

sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Ministry of Health, Spain: collaborator

Study Sites (1)

Anesthesiology Department Hospital GU Gregorio Mrañón

Madrid, Madrid, 28007, Spain

Location

Related Publications (3)

• Alonso A, de la Gala F, Vara E, Hortal J, Pineiro P, Reyes A, Simon C, Garutti I. Lung and blood perioperative metalloproteinases in patients undergoing oncologic lung surgery: Prognostic implications. Thorac Cancer. 2024 Feb;15(4):307-315. doi: 10.1111/1759-7714.15190. Epub 2023 Dec 28.

  PMID: 38155459 DERIVED

• 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.

  PMID: 30656507 DERIVED

• 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.

  PMID: 29121283 DERIVED

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Francisco de la Gala, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: June 20, 2014
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

ES (1)