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临床试验/NCT07293273
NCT07293273已完成不适用

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

Ebru Girgin Dinc1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
1
主要终点
Periprocedural Adverse Events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Pregnant women

结局指标

主要结局

Periprocedural Adverse Events

时间窗: 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).

次要结局

  • Dexmedetomidine Dose-Adverse Event Association(up to 48 hours)
  • Propofol Dose-Adverse Event Association(up to 48 hours)

研究者

发起方
Ebru Girgin Dinc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ebru Girgin Dinc

M.D., Anesthesiologist

Koşuyolu Kartal Heart Training and Research Hospital

研究点 (1)

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