Comparative Efficacy of Hyperbaric Bupivacaine With Fentanyl and Hyperbaric Ropivacaine With Fentanyl in Terms of Haemodynamic Stability and Block Characteristics in Elderly Patients Undergoing Elective Hip Hemiarthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To compare total dose of phenylephrine required intra operatively to maintain haemodynamic stability in two groups
研究概览
简要总结
This study is a randomized, parallel-group, single-centre trial comparing the efficacy of intrathecal 0.5% hyperbaric bupivacaine with fentanyl and 0.75% hyperbaric ropivacaine with fentanyl in 92 elderly patients (aged 60–80 years) undergoing elective hip hemiarthroplasty. The study will be conducted at Ballari Medical College and Research Centre, India.
The primary outcome is the total intraoperative requirement of phenylephrine (in micrograms) to maintain haemodynamic stability.
Secondary outcomes include intraoperative hemodynamic parameters, onset and duration of sensory and motor block, two-segment regression time, pain scores (NRS), postoperative nausea and vomiting (PONV), and fentanyl-related side effects such as pruritus, respiratory depression, and urinary retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective hip hemiarthroplasty 2)Patients belonging to ASA II.
排除标准
- •Patients refusal for spinal anaesthesia 2)History of allergy to study drugs 3)Any contra indication for spinal anaesthesia 4)Any severe systemic disorder 5)Patients with impaired hearing and known cognitive impairment 6)Morbid Obesity 7)Patients with poly trauma.
结局指标
主要结局
To compare total dose of phenylephrine required intra operatively to maintain haemodynamic stability in two groups
时间窗: 4 hours , 5 hours
次要结局
- Intra operative haemodynamic changes
- Onset & duration of motor blockade(1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min)
- Pain using NRS(1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min)
- Incidence & severity of PONV(5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively)
- Adverse reactions related to fentanyl(5min, 15min,30 min, 45min,60min,90min,120min, 150min,180min,210min,240min,270min,300min post operatively)
- Other adverse intra operative events including ECG changes(1 min, 2min, 3min, 4min, 6min, 8min,10min,20min,30min, 40min,60min,90min)
研究者
Dr Chaitanya Shetty
Ballari Medical College and Research Centre, Ballari