Comparison of Dexmedetomidine with Fentanyl for maintenance of intra-operative hemodynamics in hypertensive patients undergoing major surgery - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl
研究概览
简要总结
Hypertensive patients are known to have labile hemodynamics in the intra operative period. Post operative complications like myocardial infractions, arrhythmia, congestive cardiac failure, stroke and renal failure are more likely in the presence of intra operative hemodynamic instability.
Opioids like Fentanyl and Morphine are used extensively, in view of their established sedative and analgesic properties. Their significant side effects include respiratory depression, post-operative nausea and vomiting, and urinary retention.
In this study, the aim is to compare the effects of Dexmedetomidine, a highly selective Alpha-2 agonist, with those of Fentanyl on intraoperative hemodynamics,, opioid consumption, time to recovery and duration of post operative analgesia.
The study hypothesis is that Dexmedetomidine provides better hemodynamic stability intra operatively, when compared with fentanyl, while avoiding the side effects of opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Hypertensive patients under American Society of Anesthesiologists (ASA) Physical status 2 posted for major surgery under general anaesthesia.
排除标准
- •Systolic BP> 160mmHg, Diastolic BP>100mmHg
- •H/o ischemic heart disease
- •H/o cerebral vascular disease
- •Impaired renal function tests
- •Laparoscopic procedure
- •Pregnant and suspected full-stomach patients
- •Anticipated difficult airway
- •Surgery with expected significant blood loss (>25%of blood volume) and fluid shifts.
结局指标
主要结局
To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl
时间窗: To study the effect of intravenous Dexmedetomidine on intra operative hemodynamics in hypertensive patients and compare it with The effect of intravenous Fentanyl
次要结局
- Opioid consumption
- Time to recover from anesthesia (eye opening to verbal call)(End operative)
- Time to first analgesic request(Post operative)