An observational study in Hypertension, Resistant, Sympathectomy and Conscious Sedation, sponsored by Ebru Girgin Dinc. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Ebru Girgin Dinc · Observational
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 142 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Ebru Girgin Dinc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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).
Time frame: up to 48 hours
Dexmedetomidine Dose-Adverse Event Association
Association between total dexmedetomidine dose (µg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).
Time frame: up to 48 hours
Propofol Dose-Adverse Event Association
Association between total propofol dose (mg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).
Time frame: up to 48 hours
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.