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Procedural Sedation in Renal Sympathetic Denervation

NCT ID: NCT07293273

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-30

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Hypertension, Resistant Sympathectomy Conscious Sedation Procedural Sedation and Analgesia Dexmedetomidine

Keywords

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Dexmedetomidine Conscious Sedation Procedural Sedation and Analgesia sympathectomy Hypertension, resistant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ebru Girgin Dinc

OTHER

Sponsor Role lead

Responsible Party

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Ebru Girgin Dinc

M.D., Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ebru GIRGIN DINC, MD, Anesthesiologist

Role: PRINCIPAL_INVESTIGATOR

Koşuyolu Heart Training and Research Hospital

Locations

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Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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RSD-S01

Identifier Type: -

Identifier Source: org_study_id