Procedural Sedation in Renal Sympathetic Denervation

Impact of Dexmedetomidine and Fentanyl-Propofol Sedation on Peri- and Postprocedural Outcomes in Renal Sympathetic Denervation: A Single-Center Retrospective Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07293273

Enrollment

142

Registered

2025-12-19

Start date

2024-12-30

Completion date

2025-08-01

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation, Dexmedetomidine, Hypertension, Resistant, Procedural Sedation and Analgesia, Sympathectomy

Keywords

Dexmedetomidine, Conscious Sedation, Procedural Sedation and Analgesia, sympathectomy, Hypertension, resistant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age 18-80 years * Underwent renal sympathetic denervation for resistant essential hypertension (2023-2024) * Both male and female

Exclusion criteria

* Age \<18 * Pregnant women

Design outcomes

Primary

Measure	Time frame	Description
Periprocedural Adverse Events	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

Measure	Time frame	Description
Dexmedetomidine Dose-Adverse Event Association	up to 48 hours	Association between total dexmedetomidine dose (µg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).
Propofol Dose-Adverse Event Association	up to 48 hours	Association between total propofol dose (mg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).

Countries

Turkey (Türkiye)

Outcome results