Hypertension, ResistantNCT07293273
Procedural Sedation in Renal Sympathetic Denervation
An observational study of Hypertension, Resistant and Sympathectomy, run by Ebru Girgin Dinc at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Resistant, Sympathectomy, Conscious Sedation
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18-80 years
- Underwent renal sympathetic denervation for resistant essential hypertension (2023-2024)
- Both male and female
Who cannot join
- Age <18
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kosuyolu Heart Training and Research Hospital
Istanbul, Kartal, 34846
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Resistant, Sympathectomy, Conscious Sedation, Procedural Sedation and Analgesia, Dexmedetomidine
- Keywords
- Dexmedetomidine, Conscious Sedation, Procedural Sedation and Analgesia, sympathectomy, Hypertension, resistant
- Medical subject headings
- Hypertension, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total Intraprocedural Fentanyl Consumption
Total fentanyl administered during renal sympathetic denervation, expressed as a weight-normalised dose (µg/kg). Values are reported for all three sedation groups: midazolam-fentanyl (Group M-F), propofol-based (Group P) and dexmedetomidine-based (Group D). The primary comparison is Group P versus Group D.
Measured: Up to the end of the procedure
Secondary outcomes (5)
Dexmedetomidine Dose-Adverse Event Association
Association between total dexmedetomidine dose (µg/kg) and the occurrence of the composite periprocedural adverse event (yes/no).
Measured: 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).
Measured: up to 48 hours
Dexmedetomidine Infusion Rate-Fentanyl Consumption Association
Within Group D, the association between the weight-based dexmedetomidine infusion rate (µg/kg/h) and total fentanyl consumption (µg/kg).
Measured: Up to the end of the procedure
Fentanyl-Free Procedure Completion
Within Group D, completion of the procedure without any fentanyl administration (yes/no). An exploratory receiver operating characteristic (ROC) analysis identifies the dexmedetomidine infusion rate threshold (µg/kg/h) associated with fentanyl-free completion.
Measured: Up to the end of the procedure
Composite Periprocedural Adverse Events
Occurrence of ≥1 of the following: respiratory depression (SpO₂ <90% for ≥1 min or need for airway intervention or ventilatory support), arrhythmia requiring treatment, need for vasoactive drugs, increase in serum creatinine meeting KDIGO criteria, or elevation in AST/ALT (>2× baseline or ULN).
Measured: Up to the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start30 Dec 2024
- Primary completion30 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebru Girgin Dinc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Girgin Dinc, Koşuyolu Kartal Heart Training and Research Hospital
- Investigators
- Ebru GIRGIN DINC, MD, Anesthesiologist, Principal investigator, Koşuyolu Heart Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293273
- Sponsor's protocol ID
- RSD-S01
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine and Fentanyl-Propofol Sedation on Peri- and Postprocedural Outcomes in Renal Sympathetic Denervation: A Single-Center Retrospective Study
- ClinicalTrials.gov ID
- NCT07293273
- Acronym / sponsor ID
- RSD-S01
- Conditions
- Hypertension, Resistant, Sympathectomy, Conscious Sedation, Procedural Sedation and Analgesia, Dexmedetomidine
- Keywords
- Dexmedetomidine, Conscious Sedation, Procedural Sedation and Analgesia, sympathectomy, Hypertension, resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ebru Girgin DincUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18-80 years
- Underwent renal sympathetic denervation for resistant essential hypertension (2023-2024)
- Both male and female
Key exclusion criteria (2 listed)
- Age <18
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Intraprocedural Fentanyl Consumption
Time frame: Up to the end of the procedure
Total fentanyl administered during renal sympathetic denervation, expressed as a weight-normalised dose (µg/kg). Values are reported for all three sedation groups: midazolam-fentanyl (Group M-F), propofol-based (Group P) and dexmedetomidine-based (Group D). The primary comparison is Group P versus Group D.
5 secondary outcomes
Dexmedetomidine Dose-Adverse Event Association
Time frame: up to 48 hours
Propofol Dose-Adverse Event Association
Time frame: up to 48 hours
Dexmedetomidine Infusion Rate-Fentanyl Consumption Association
Time frame: Up to the end of the procedure
Fentanyl-Free Procedure Completion
Time frame: Up to the end of the procedure
Composite Periprocedural Adverse Events
Time frame: Up to the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru GIRGIN DINC, MD, Anesthesiologist principal investigator
Koşuyolu Heart Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Resistant and Sympathectomy, run by Ebru Girgin Dinc at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intraprocedural Fentanyl Consumption (time frame: Up to the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.