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Abdominal Aortic AneurysmNCT07857005

Dexmedetomidine vs Propofol Sedation in Endovascular Aortic Repair

An observational study of Abdominal Aortic Aneurysm and Acute Kidney Injury, run by Bursa City Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Endovascular aortic repair (EVAR) is increasingly performed under local anesthesia with intravenous sedation, but the optimal sedative agent has not been established. Dexmedetomidine provides cooperative sedation with minimal respiratory depression and may have renoprotective effects, whereas propofol is widely used… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Dexmedetomidine and propofol
Type of treatment
Injection or infusion
How many people
282 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Sep 2026to 15 Sep 2026
Phase
Observational
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients who underwent endovascular aortic repair under local anesthesia and intravenous sedation in the operating room of Bursa City Hospital between 18 October 2019 and 5 August 2026.

Who may be able to join

  • Age 18 years or older
  • Underwent endovascular aortic repair in the operating room of Bursa City Hospital between 18 October 2019 and 5 August 2026
  • Received local anesthesia with dexmedetomidine-based or propofol-based intravenous sedation

Who cannot join

  • General anesthesia
  • Emergency procedures
  • Missing data in medical records

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Bursa City Hospital Scientific Research Ethics Committee

    Bursa, Bursa/nilufer, 16250

  • Bursa City Hospital

    Bursa, Nilufer, 16110

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Dexmedetomidine-Based Versus Propofol-Based Sedation in Endovascular Aortic Repair: A Retrospective Cohort Study

Endovascular aortic repair (EVAR) is increasingly performed under local anesthesia with intravenous sedation, but the optimal sedative agent has not been established. Dexmedetomidine provides cooperative sedation with minimal respiratory depression and may have renoprotective effects, whereas propofol is widely used but can cause respiratory depression and hypotension.

This single-center retrospective cohort study compares dexmedetomidine-based and propofol-based sedation in adult patients who underwent EVAR under local anesthesia and sedation at Bursa City Hospital. The primary outcome is postoperative acute kidney injury (AKI) defined by KDIGO serum creatinine criteria. Secondary outcomes include intensive care unit (ICU) admission, ICU length of stay, hospital length of stay, and in-hospital mortality.

Read the detailed description

Background: Acute kidney injury develops in approximately 15-20% of patients after EVAR and is associated with worse short- and long-term survival. Proposed renoprotective mechanisms of dexmedetomidine include attenuation of sympathoadrenal activity, suppression of renin release, and support of renal vasodilation. Randomized data in endovascular repair of type B aortic dissection and meta-analyses in cardiac and aortic surgery suggest a reduction in AKI with dexmedetomidine, but data on its use as the primary sedative agent during EVAR under local anesthesia are limited.

Hypothesis: Through its sympatholytic effect and more stable perioperative hemodynamics, dexmedetomidine-based sedation is associated with a lower incidence of postoperative AKI and shorter ICU and hospital length of stay compared with propofol-based sedation.

Design and setting: Single-center, retrospective cohort study at Bursa City Hospital, Bursa, Türkiye, reported according to the STROBE statement. Records of all adult patients who underwent EVAR in the operating room between 18 October 2019 and 5 August 2026 are reviewed. Patients are allocated to two groups according to the sedative agent received (dexmedetomidine or propofol). The choice of sedative agent was at the discretion of the attending anesthesiologist.

Anesthetic management (institutional protocol): Standard ASA monitoring and radial arterial catheterization under local anesthesia, oxygen 4-6 L/min via nasal cannula, and local anesthetic infiltration of vascular access sites. Dexmedetomidine group: 0.5 µg/kg IV loading dose over 10 minutes followed by 0.2-1.0 µg/kg/h infusion. Propofol group: IV infusion titrated to the lowest dose providing immobility while preserving spontaneous breathing and airway patency, with 10 mg IV boluses as needed. After the procedure, patients with a Modified Aldrete score of 9 or higher are transferred to the ward and others to the ICU.

Data collection: Data are obtained from electronic health records, anesthesia charts, ICU records, and institutional laboratory reports, including age, sex, ASA physical status, comorbidities (hypertension, diabetes mellitus, coronary artery disease, asthma/COPD, congestive heart failure, cerebrovascular disease, chronic kidney disease), baseline serum creatinine (lowest value within the preceding 3 months), serum creatinine and eGFR (CKD-EPI) on postoperative days 1, 2 and 7, ICU admission, ICU and hospital length of stay, and in-hospital mortality.

Statistical analysis: No formal sample size calculation is performed; all eligible patients during the study period are included. Continuous variables are compared with Welch's t-test or Mann-Whitney U test, and categorical variables with the chi-square or Fisher's exact test. Absolute risk difference, relative risk and odds ratio with 95% confidence intervals are calculated for the primary outcome. Multivariable logistic regression adjusted for sedative agent, age, sex, baseline eGFR, and comorbidities associated with AKI at p<0.10 in univariable analysis is used to account for confounding. Model fit is assessed with the Hosmer-Lemeshow test and discrimination with the area under the ROC curve. Two-sided p<0.05 is considered significant.

Keywords
Endovascular Aneurysm Repair, EVAR, Dexmedetomidine, Propofol, Conscious Sedation, Monitored Anesthesia Care, Local Anesthesia, KDIGO
Medical subject headings
Aortic Aneurysm, Abdominal, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Intravenous 0.5 µg/kg loading dose over 10 minutes followed by 0.2-1.0 µg/kg/h maintenance infusion throughout the procedure, in addition to local anesthetic infiltration of vascular access sites.

  • propofolDrug

    Intravenous infusion titrated to the lowest dose providing immobility while preserving spontaneous breathing and airway patency, with 10 mg IV boluses as needed, in addition to local anesthetic infiltration of vascular access sites.

Study groups in NCT07857005
Study groupRoleWhat they receive
Dexmedetomidine GroupAdult patients who underwent elective EVAR under local anesthesia with dexmedetomidine-based intraoperative sedation.
Receives: Drug: Dexmedetomidine
Propofol GroupAdult patients who underwent elective EVAR under local anesthesia with propofol-based intraoperative sedation.
Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative acute kidney injury (AKI)

    AKI defined by the 2012 KDIGO serum creatinine criteria: an increase of at least 0.3 mg/dL (26.5 µmol/L) from baseline within 48 hours (highest of postoperative day 1 and 2 values), or an increase to at least 1.5 times baseline within 7 days (highest of postoperative day 1, 2 and 7 values). Baseline creatinine is the lowest value within the preceding 3 months. AKI is staged according to KDIGO (stage 1-3). Urine output criteria are not used.

    Measured: From the end of the procedure through postoperative day 7

Secondary outcomes (4)
  1. ICU admission

    Proportion of patients requiring intensive care unit admission after the procedure.

    Measured: Within 24 hours after the end of the procedure

  2. ICU length of stay

    Duration of ICU stay in hours among patients admitted to the ICU; prolonged ICU stay is also assessed using thresholds of more than 24 hours and more than 48 hours.

    Measured: From ICU admission to ICU discharge, up to 30 days

  3. Hospital length of stay

    Duration of postoperative hospital stay in hours.

    Measured: From the end of the procedure to hospital discharge, up to 180 days

  4. In-hospital mortality

    Death from any cause during the index hospitalization.

    Measured: From the procedure until hospital discharge, up to 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2026
  2. Study start1 Sep 2026
  3. Primary completion15 Sep 2026
  4. Study completion15 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07857005
Sponsor's protocol ID
E-EVAR
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared. De-identified data are available from the corresponding author upon reasonable request.

Publications

  • Cho JS, Shim JK, Soh S, Kim MK, Kwak YL. Perioperative dexmedetomidine reduces the incidence and severity of acute kidney injury following valvular heart surgery. Kidney Int. 2016 Mar;89(3):693-700. doi: 10.1038/ki.2015.306.

    PubMed 26444030
  • Hashmi TM, Ashraf H, Burhan M, Zia R, Ahmed M, Ahmed R, Aized MT. Effects of Dexmedetomidine on Acute Kidney Injury and Perioperative Outcomes in Aortic Vascular Surgery: A Systematic Review and Meta-Analysis. Semin Cardiothorac Vasc Anesth. 2025 Dec;29(4):291-299. doi: 10.1177/10892532251346645. Epub 2025 Jun 25.

    PubMed 40563160
  • Shan XS, Dai HR, Zhao D, Yang BW, Feng XM, Liu H, Peng K, Ji FH. Dexmedetomidine reduces acute kidney injury after endovascular aortic repair of Stanford type B aortic dissection: A randomized, double-blind, placebo-controlled pilot study. J Clin Anesth. 2021 Dec;75:110498. doi: 10.1016/j.jclinane.2021.110498. Epub 2021 Sep 3.

    PubMed 34488061
  • Jhaveri KD, Saratzis AN, Wanchoo R, Sarafidis PA. Endovascular aneurysm repair (EVAR)- and transcatheter aortic valve replacement (TAVR)-associated acute kidney injury. Kidney Int. 2017 Jun;91(6):1312-1323. doi: 10.1016/j.kint.2016.11.030. Epub 2017 Mar 17.

    PubMed 28318632
  • Geisbusch P, Katzen BT, Machado R, Benenati JF, Pena C, Tsoukas AI. Local anaesthesia for endovascular repair of infrarenal aortic aneurysms. Eur J Vasc Endovasc Surg. 2011 Oct;42(4):467-73. doi: 10.1016/j.ejvs.2011.05.018. Epub 2011 Jun 20.

    PubMed 21693382
  • Ruppert V, Leurs LJ, Steckmeier B, Buth J, Umscheid T. Influence of anesthesia type on outcome after endovascular aortic aneurysm repair: an analysis based on EUROSTAR data. J Vasc Surg. 2006 Jul;44(1):16-21; discussion 21. doi: 10.1016/j.jvs.2006.03.039.

    PubMed 16828420
  • De Virgilio C, Romero L, Donayre C, Meek K, Lewis RJ, Lippmann M, Rodriguez C, White R. Endovascular abdominal aortic aneurysm repair with general versus local anesthesia: a comparison of cardiopulmonary morbidity and mortality rates. J Vasc Surg. 2002 Nov;36(5):988-91. doi: 10.1067/mva.2002.128314.

    PubMed 12422110
  • Brown BJ, Zakhary S, Rogers L, Ellis-Stoll C, Gable D, Ramsay MA. Use of dexmedetomidine versus general anesthesia for endovascular repair of abdominal aortic aneurysms. Proc (Bayl Univ Med Cent). 2006 Jul;19(3):213-5. doi: 10.1080/08998280.2006.11928164.

    PubMed 17252035

Questions about this trial

What is this clinical trial studying?

An observational study of Abdominal Aortic Aneurysm and Acute Kidney Injury, run by Bursa City Hospital at 2 sites in Turkey (Türkiye).

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 3 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). 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.

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?

Incidence of postoperative acute kidney injury (AKI) (time frame: From the end of the procedure through postoperative day 7). 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 NCT07857005, which also lists 8 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 5 Oct 2026.

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