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Dexmedetomidine vs Propofol Sedation in Endovascular Aortic Repair

NCT07857005 — Completed, 282 participants, Bursa City Hospital

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

RegistryNCT07857005
StatusCompleted
Study typeObservational
Enrollment282 (Actual)
SponsorBursa City Hospital (Other gov)
ConditionsAbdominal Aortic Aneurysm, Acute Kidney Injury
InterventionsDexmedetomidine, propofol (Drug)
Datesstart 2026-09-01, primary completion 2026-09-15, completion 2026-09-15, first posted 2026-10-05, last updated 2026-10-05
Locations2 sites in Turkey (Türkiye)

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-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 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Dexmedetomidine GroupDrug: DexmedetomidineAdult patients who underwent elective EVAR under local anesthesia with dexmedetomidine-based intraoperative sedation.
Propofol GroupDrug: propofolAdult patients who underwent elective EVAR under local anesthesia with propofol-based intraoperative sedation.
  • Dexmedetomidine (Drug): 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.
  • propofol (Drug): 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.

+Outcome measures

Primary outcomes

  • Incidence of postoperative acute kidney injury (AKI) [From the end of the procedure through postoperative day 7]: 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.

Secondary outcomes

  • ICU admission [Within 24 hours after the end of the procedure]: Proportion of patients requiring intensive care unit admission after the procedure.
  • ICU length of stay [From ICU admission to ICU discharge, up to 30 days]: 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.
  • Hospital length of stay [From the end of the procedure to hospital discharge, up to 180 days]: Duration of postoperative hospital stay in hours.
  • In-hospital mortality [From the procedure until hospital discharge, up to 180 days]: Death from any cause during the index hospitalization.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

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

+Locations (2)

FacilityCityCountryStatus
Bursa City Hospital Scientific Research Ethics CommitteeBursa, Bursa/niluferTurkey (Türkiye)
Bursa City HospitalBursa, NiluferTurkey (Türkiye)

+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17252035

+Investigators

  • Esat M DEMIREL, MD, Study chair, Bursa City Hospital

My Notes