Procedural Sedation in Renal Sympathetic Denervation

NCT07293273 | Completed DMC

• 1 other identifier: RSD-S01
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dexmedetomidine Dose-Adverse Event Association

  up to 48 hours

• Propofol Dose-Adverse Event Association

  up to 48 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Age \<18
• Pregnant women

Sponsors & Collaborators

• Ebru Girgin Dinc: lead

Study Sites (1)

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, 34846, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Agnosia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebru GIRGIN DINC, MD, Anesthesiologist

  Koşuyolu Heart Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Anesthesiologist

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)