Comparative analysis of Pre-operative Prazosin versus Am-lodipine on Intraoperative Hemodynamic Instability in Patients with Pheochromocytoma/Paraganglioma (PPGL): An Open-label Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To determine the efficacy of amlodipine in reducing the intra-operative hemodynamic instability duration (%) in patients with PPGL compared to prazosin
研究概览
简要总结
| Even |
| though alpha-blocker is used as frequently for pre-operative blockade in |
| PPGL, prospective randomized controlled trials comparing various antihypertensive |
| agents on peri-operative hemodynamic instability are lacking. There are various institutional protocols |
| and some institutions are using calcium-channel blockers as the first line of |
| management. |
Even though there are limited studies,study results revealed calcium channel blockers can be used as an alternative to alpha-blockers and even superior hemodynamic control.
Novelty:
Since PPGL is a rare clinical condition, there are fewer studies on the assessment of intraoperative hemodynamic instability.
There are limited studies on calcium channel blockers as the first line of pre-operative treatment in PPGL
Expected outcomes:
We are expecting a reduction in the incidence and duration of hypotensive and hypertensive episodes during the perioperative period while using amlodipine as compared to prazosin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age- 18-65 years
- •Secretory PPGL.
- •Elevated plasma-free meta-nephrine and or plasma-free normetanephrine irre-spective of Blood pressure recordings
- •Planned for surgical removal.
排除标准
- •Bilateral tumour
- •Distant metastasis
- •Pregnancy
- •Incapability to adhere to study protocol.
结局指标
主要结局
To determine the efficacy of amlodipine in reducing the intra-operative hemodynamic instability duration (%) in patients with PPGL compared to prazosin
时间窗: At the end of surgery
次要结局
- To determine the efficacy of amlodipine in reducing the intraoperative hemodynamic instability score in patients with PPGL compared to prazosin
研究者
RAJKAMAL M
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),PONDICHERRY