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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Procedural Sedation and Analgesia; Conscious Sedation; Sympathectomy; Hypertension, Resistant

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 Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kartal
    • Istanbul, Kartal, Turkey (Türkiye), 34846
      • Kosuyolu Heart Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Association between total propofol dose (mg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).	up to 48 hours

Collaborators and Investigators

• Sponsor: Ebru Girgin Dinc
• Investigators: Principal Investigator: Ebru GIRGIN DINC, MD, Anesthesiologist, Kosuyolu Heart Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Procedural Sedation and Analgesia; Conscious Sedation; sympathectomy; Hypertension, resistant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypertension; Agnosia
• Other Study ID Numbers: RSD-S01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No