Comparison of Dexmedetomidine-Based Versus Propofol-Based Sedation in Endovascular Aortic Repair: A Retrospective Cohort Study
| Registry | NCT07857005 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 282 (Actual) |
| Sponsor | Bursa City Hospital (Other gov) |
| Conditions | Abdominal Aortic Aneurysm, Acute Kidney Injury |
| Interventions | Dexmedetomidine, propofol (Drug) |
| Dates | start 2026-09-01, primary completion 2026-09-15, completion 2026-09-15, first posted 2026-10-05, last updated 2026-10-05 |
| Locations | 2 sites in Turkey (Türkiye) |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dexmedetomidine Group | Drug: Dexmedetomidine | Adult patients who underwent elective EVAR under local anesthesia with dexmedetomidine-based intraoperative sedation. | |
| Propofol Group | Drug: propofol | Adult patients who underwent elective EVAR under local anesthesia with propofol-based intraoperative sedation. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Bursa City Hospital Scientific Research Ethics Committee | Bursa, Bursa/nilufer | Turkey (Türkiye) | |
| Bursa City Hospital | Bursa, Nilufer | Turkey (Türkiye) |