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This retrospective, single-center study investigates the effects of two different sedation regimens-dexmedetomidine versus fentanyl-propofol-on clinical outcomes in patients undergoing catheter-based renal sympathetic denervation for resistant hypertension. The study focuses on peri-procedural safety, recovery, and overall tolerability of sedation approaches in this interventional setting.
Renal sympathetic denervation has emerged as a therapeutic option for patients with resistant hypertension, yet optimal sedation practices remain unclear. Sedation during catheter-based procedures requires a balance between patient comfort, hemodynamic stability, and minimization of respiratory complications. Dexmedetomidine offers sedative and analgesic effects with minimal respiratory depression, whereas fentanyl-propofol provides rapid, effective sedation but may increase the risk of hemodynamic and respiratory instability. This study retrospectively compares the two strategies by examining intraoperative physiological parameters, complication profiles, and post-procedural recovery measures, aiming to generate evidence that can support anesthesiologists in selecting safer and more effective sedation protocols for this high-risk patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Sympathetic Denervation Patients (Retrospective Cohort) | All patients who underwent renal sympathetic denervation for resistant hypertension will be retrospectively included. Within this cohort, patients will be categorized into two subgroups according to sedation regimen: Group D: Dexmedetomidine sedation Group P: Fentanyl + Propofol sedation Comparative analysis will assess peri- and post-procedural safety, hemodynamic stability, and recovery outcomes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural Adverse Events | The primary outcome is a composite of periprocedural adverse events during or immediately after renal sympathetic denervation, defined as the occurrence of any of the following: respiratory depression (SpO₂ <90% ≥1 min or need for airway/ventilation), arrhythmia requiring treatment, need for vasoactive drugs, increase in serum creatinine (KDIGO criteria), or elevation in AST/ALT (>2× baseline or ULN). Patients will be positive if ≥1 event occurs. Comparative analysis will be performed between sedation with dexmedetomidine (Group D) and fentanyl + propofol (Group P). | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dexmedetomidine Dose-Adverse Event Association | Association between total dexmedetomidine dose (µg/kg) and the occurrence of the composite periprocedural adverse event (yes/no). | up to 48 hours |
| Propofol Dose-Adverse Event Association |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients aged 18 to 80 years who underwent renal sympathetic denervation for resistant essential hypertension. Both male and female patients are eligible. Patients younger than 18 years of age and pregnant women are excluded from the analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Ebru GIRGIN DINC, MD, Anesthesiologist | Koşuyolu Heart Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosuyolu Heart Training and Research Hospital | Istanbul | Kartal | 34846 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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Association between total propofol dose (mg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).
| up to 48 hours |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |