INFUSION OF NOREPINEPHRINE VERSUS PHENYLEPHRINE FOR PREVENTION OF SUBARACHNOID BLOCK INDUCED HYPOTENSION IN ELDERLY PATIENTS UNDERGOING HIP AND FEMUR SURGERIES
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Episodes of hypotension (defined as Systolic blood pressure less than 80% of baseline or an absolute value of less than 100 mmHg).
研究概览
简要总结
Spinal anaesthesia is frequently used for lower extremity surgeries.Sympathetic blockade after spinal anaesthesia results in venodilation which reduces venous return and hence cardiac output and results in hypotension . Therefore, prophylactic use of alpha-adrenergic agonist drugs is recommended which act by inducing constriction of compliant veins , effectively reversing the vasodilatory effects of spinal anaesthesia.
A prospective , interventional , double blinded , randomised study will be conducted on elderly more than 60 years old patients posted for hip and femur surgeries under sub arachnoid block. In this study we aim to compare the effect of using prophylactic Norepinephrine versus Phenylephrine infusion for prevention of spinal induced hypotension in elderly population undergoing hip and femur surgeries.
A randomized controlled trial will be conducted on 134 elderly patients ( > 60 years of age ) undergoing hip and femur surgeries under spinal anaesthesia. An arterial line will be secured using a 20 G arterial cannula in the radial artery. The patients will be divided into two groups: Norepinephrine (NE) and Phenylephrine (PE) -67 each -depending on the drug administered which will be started before giving sub arachnoid block to the patient . All patients will be administered 2.2 ml volume of bupivacaine 0.5% (1.7 ml) with 25 micrograms (0.5 ml) of fentanyl to achieve subarachnoid block Monitoring of invasive arterial blood pressure will be done for first 45 minutes of surgery and readings will be noted every 2 minutes
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Elderly patients above 60 years of age posted for hip and femur surgeries.
排除标准
- •Patients with history of allergy to any of the study drugs
- •Patients with contraindications of spinal anaesthesia
- •Patient refusal.
结局指标
主要结局
Episodes of hypotension (defined as Systolic blood pressure less than 80% of baseline or an absolute value of less than 100 mmHg).
时间窗: Upto 45 minutes after sub arachnoid block
次要结局
- Incidence of hypertension(Upto 45 minutes after sub arachnoid block)
- Total amount of Phenylephrine or Norepinephrine
- Episodes of Bradycardia(Upto 45 minutes after sub arachnoid block)