Pulmonary ResectionPhase 4NCT02168751
Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents
A Phase 4 study testing propofol and Sevoflurane in people with Pulmonary Resection, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Resection
- What is being tested?
- propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Anesthesiology Department Hospital GU Gregorio Mrañón
Madrid, Madrid, 28007
About this study
Official title: STUDY OF PULMONARY AND SYSTEMIC INFLAMMATORY RESPONSE SECONDARY TO LUNG RESECTION SURGERY USING INTRAVENOUS ANESTHESIA VERSUS INHALATION ANESTHESIA WITH HALOGENATED AGENTS
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
- Being tested
- propofol, Sevoflurane
- Keywords
- one lung ventilation, inflammatory response, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
SevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | propofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery Receives: Drug: propofol |
| sevoflurane | Experimental | Sevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline and 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Spain
- Responsible party
- Sponsor
- Investigators
- Francisco de la Gala, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168751
- Sponsor's protocol ID
- FIBHGM-ECNC003-2011
- Other IDs
- 2011-002294-29
- Status last verified
- Apr 2016
- First submitted
- 19 Jul 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38155459Garutti 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.
PubMed 30656507de 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.
PubMed 29121283
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF PULMONARY AND SYSTEMIC INFLAMMATORY RESPONSE SECONDARY TO LUNG RESECTION SURGERY USING INTRAVENOUS ANESTHESIA VERSUS INHALATION ANESTHESIA WITH HALOGENATED AGENTS
- ClinicalTrials.gov ID
- NCT02168751
- Acronym / sponsor ID
- FIBHGM-ECNC003-2011
- Conditions
- Pulmonary Resection
- Keywords
- one lung ventilation, inflammatory response, thoracic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Ministry of Health, Spain
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofolpropofol doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery |
| sevoflurane | Experimental | Drug: SevofluraneSevoflurane doses to maintain hypnoses between 40-60 bis(Bispectral Index Scale)during the lung resection surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol | Drug | propofol |
| Sevoflurane | Drug | sevoflurane |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 38155459Alonso 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.
- Derived from this study: PubMed 30656507Garutti 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.
- Derived from this study: PubMed 29121283de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco de la Gala, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and Sevoflurane in people with Pulmonary Resection, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammation markers in plasma and bronchoalveolar lavage (time frame: baseline and 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168751, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.