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NCT Number: NCT07293273

Procedural Sedation in Renal Sympathetic Denervation

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.

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Key information

Conditions

Hypertension, Resistant Agnosia Cardiovascular Diseases Conscious Sedation Dexmedetomidine Hypertension Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Procedural Sedation and Analgesia Signs and Symptoms Sympathectomy Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, 34846, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Dexmedetomidine Dose-Adverse Event Association

    Time frame: up to 48 hours

    Association between total dexmedetomidine dose (µg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).

  2. Propofol Dose-Adverse Event Association

    Time frame: up to 48 hours

    Association between total propofol dose (mg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).

Sponsors and collaborators

Lead sponsor

Ebru Girgin Dinc

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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