Renal FailurePhase 4NCT03917186
Desflurane vs. Sevoflurane in Endovascular Aortic Repair
A Phase 4 study testing Sevoflurane and Desflurane in people with Renal Failure, run by Begoña Quintana Villamandos at 1 site in Spain.
Trial summary
Randomized Clinical Trial following the evaluation of the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2017to 16 Mar 2021
- 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
- older than 18 years undergoing elective endovascular aortic repair
- who have signed informed consent
Who cannot join
- urgent surgery
- with known hypersensitivity to Desflurane or Sevoflurane.
- Renal failure in hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fast-track in Endovascular Aortic Aneurysm Repair With Desflurane and Sevoflurane: a Randomized Clinical Trial
Randomized Clinical Trial following the evaluation of the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.
Read the detailed description
Randomized Clinical Trial to evaluate the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.
Secondary Endpoint: Among secondary endpoints we will evaluate clinical variables such emergence and recovery characteristics (time to extubation and time to emergence-open eyes and response to verbal command), the need for postoperative mechanical ventilation, the post-anesthesia recovery score and ICU length of stay.
- Conditions
- Renal Failure
- Being tested
- Sevoflurane, Desflurane
- Keywords
- Desflurane, Sevoflurane, Endovascular aortic repair
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
administration of sevoflurane
DesfluraneDrug
administration of Desflurane
| Study group | Role | What they receive |
|---|---|---|
| Group sevoflurane | Active comparator | Administration under labelling conditions Receives: Drug: Sevoflurane |
| Group desflurane | Experimental | Administration under labelling conditions Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biochemical parameters
NGAL in urine
Measured: All these parameters will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
Cystatin C(mg/L) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
Creatinine(mg/dL) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
sodium(mMol/L) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
potassium(mMol/L) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
Chloride(mMol/L) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
albumin(g/dL) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
osmolarity(mOsm/Kg) in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
NGAL in plasma
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
Creatinine(mg/dL) in urine
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
sodium(mMol/L) in urine
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
potassium(mMol/L) in urine
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
Chloride(mMol/L) in urine
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
albumin(g/dL) in urine
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Change in Biochemical parameters
osmolarity(mOsm/Kg) in urine
Measured: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Secondary outcomes (6)
Need for postoperative mechanical ventilation
hours of mechanical ventilation in ICU
Measured: 24 hours
ICU length of stay
hours in ICU
Measured: up to 24 hours
anesthetic recovery
time to extubation(minutes).
Measured: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded at baseline and after surgery. time frame upto 1 hour(stimated)
anesthetic recovery
time to spontaneous eye opening(minutes)
Measured: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded after surgery. timeframe up to 1 hour(stimated).
anesthetic recovery
time until first response to verbal commands(minutes)
Measured: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded after surgery. timeframe up to 1 hour(stimated).
anesthetic recovery
The post-anesthesia recovery score ( Modified Aldrete score) (0-1-2 from worse to better)
Measured: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded at baseline and after surgery. timeframe 1 hour(stimated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start20 Sep 2017
- Primary completion31 Dec 2020
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Begoña Quintana Villamandos
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Begoña Quintana Villamandos, Hospital General Universitario Gregorio Marañon
- Investigators
- Begoña Quintana, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917186
- Sponsor's protocol ID
- DESEVAR
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2017
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arnalich-Montiel A, Barrio-Perez IM, Burgos-Santamaria A, Fernandez-Riveira C, Lazaro A, Gonzalez-Nicolas MA, Rio J, Bellon JM, Canal MI, Ligero JM, Quintana-Villamandos B. Influence of the type of volatile anesthetic on the development of acute kidney injury after endovascular repair of aortic aneurysm: a randomized controlled trial (DESEVAR study). Front Pharmacol. 2025 Sep 25;16:1660359. doi: 10.3389/fphar.2025.1660359. eCollection 2025.
PubMed 41079741
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track in Endovascular Aortic Aneurysm Repair With Desflurane and Sevoflurane: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03917186
- Acronym / sponsor ID
- DESEVAR
- Conditions
- Renal Failure
- Keywords
- Desflurane, Sevoflurane, Endovascular aortic repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Begoña Quintana VillamandosUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 16 Apr 2019 (actual)
- 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.
Randomized Clinical Trial following the evaluation of the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.
Detailed description
Randomized Clinical Trial to evaluate the impact on renal function in patients undergoing endovascular aortic aneurysm repair with two anesthetics protocols (Desflurane versus Sevoflurane) on the first 24 hours after surgery.
Secondary Endpoint: Among secondary endpoints we will evaluate clinical variables such emergence and recovery characteristics (time to extubation and time to emergence-open eyes and response to verbal command), the need for postoperative mechanical ventilation, the post-anesthesia recovery score and ICU length of stay.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group sevoflurane | Active comparator | Drug: SevofluraneAdministration under labelling conditions |
| Group desflurane | Experimental | Drug: DesfluraneAdministration under labelling conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years undergoing elective endovascular aortic repair
- who have signed informed consent
Key exclusion criteria (3 listed)
- urgent surgery
- with known hypersensitivity to Desflurane or Sevoflurane.
- Renal failure in hemodialysis
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 |
|---|---|---|
| Sevofluraneadministration of sevoflurane | Drug | Group sevoflurane |
| Desfluraneadministration of Desflurane | Drug | Group desflurane |
Primary outcome
Change in Biochemical parameters
Time frame: All these parameters will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
NGAL in urine
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Cystatin C(mg/L) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Creatinine(mg/dL) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
sodium(mMol/L) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
potassium(mMol/L) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Chloride(mMol/L) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
albumin(g/dL) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
osmolarity(mOsm/Kg) in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
NGAL in plasma
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Creatinine(mg/dL) in urine
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
sodium(mMol/L) in urine
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
potassium(mMol/L) in urine
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
Chloride(mMol/L) in urine
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
albumin(g/dL) in urine
Change in Biochemical parameters
Time frame: will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups
osmolarity(mOsm/Kg) in urine
6 secondary outcomes
Need for postoperative mechanical ventilation
Time frame: 24 hours
ICU length of stay
Time frame: up to 24 hours
anesthetic recovery
Time frame: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded at baseline and after surgery. time frame upto 1 hour(stimated)
anesthetic recovery
Time frame: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded after surgery. timeframe up to 1 hour(stimated).
anesthetic recovery
Time frame: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded after surgery. timeframe up to 1 hour(stimated).
anesthetic recovery
Time frame: These variable will be recorded immediately after surgery (from anesthetics discontinuation). The postanesthesia recovery score before will be recorded at baseline and after surgery. timeframe 1 hour(stimated)
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 21 Nov 2023.
- Derived from this study: PubMed 41079741Arnalich-Montiel A, Barrio-Perez IM, Burgos-Santamaria A, Fernandez-Riveira C, Lazaro A, Gonzalez-Nicolas MA, Rio J, Bellon JM, Canal MI, Ligero JM, Quintana-Villamandos B. Influence of the type of volatile anesthetic on the development of acute kidney injury after endovascular repair of aortic aneurysm: a randomized controlled trial (DESEVAR study). Front Pharmacol. 2025 Sep 25;16:1660359. doi: 10.3389/fphar.2025.1660359. eCollection 2025.
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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.
Begoña Quintana, 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 Sevoflurane and Desflurane in people with Renal Failure, run by Begoña Quintana Villamandos 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 2 inclusion and 3 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 21 Nov 2023. 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 Biochemical parameters (time frame: All these parameters will be evaluated at baseline (presurgery), at the end surgery and 24 hours after surgery in both study groups). The study lists 15 primary outcomes in all. 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 NCT03917186, which also lists 1 linked publication.
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 21 Nov 2023.