Impact of Dexmedetomidine and Fentanyl-Propofol Sedation on Peri- and Postprocedural Outcomes in Renal Sympathetic Denervation: A Single-Center Retrospective Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ebru Girgin Dinc
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Periprocedural Adverse Events
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-80 years
- •Underwent renal sympathetic denervation for resistant essential hypertension (2023-2024)
- •Both male and female
Exclusion Criteria
- •Pregnant women
Outcomes
Primary Outcomes
Periprocedural Adverse Events
Time Frame: up to 48 hours
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).
Secondary Outcomes
- Dexmedetomidine Dose-Adverse Event Association(up to 48 hours)
- Propofol Dose-Adverse Event Association(up to 48 hours)
Investigators
Ebru Girgin Dinc
M.D., Anesthesiologist
Koşuyolu Kartal Heart Training and Research Hospital