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临床试验/CTRI/2024/03/064165
CTRI/2024/03/064165已完成4 期

A randomised double blinded study comparing prophylactic noradrenaline infusion and phenylephrine infusion after preloading with crystalloid for prevention of hypotension in geriatric patients undergoing proximal femoral nailinig under spinal anaesthesia.

Dr Tharigonda Balaji1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月28日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Prevention Of Spinal Hypotension

研究概览

简要总结

Aim of this study is to compare effectiveness of prophylactic norepinephrine infusion and phenylephrine infusion after preloading with crystalloid in preventing hypotension.The primary objective of this study is  to compare the effect of prophylactic norepinephrine infusion and phenylephrine infusion after preloading with crystalloid in preventing hypotension in geriatric patients undergoing proximal femoral nailing surgeries under spinal anaesthesia. Secondary objectives are to assess the incidence of adverse events between the two groups. Total number of 60 patients between the age group of 65-80years, belonging to ASA physical status ii/iii, posted for proximal femoral  nailing surgeries under spinal anaesthesia will be recruited and randomly assigned into two equal groups using computer generated random list. All patients will be preloaded with crystalloids 10ml/kg. After preloading the patients with crystalloids 10ml/kg, subarachnoid block will be achieved with intrathecal 0.5% bupivacaine heavy 2.5ml combined with 25 mics fentanyl. Immediately following subarachnoid block, patients in Group A (n-30) will  receive inj.phenylephrine infusion at rate of  0.5mcg/kg/min and patients in Group B (n-30) will receive  inj.norepinephrine infusion at rate of 0.05 mcg/kg/min. Haemodynamic parameters including mean arterial pressure (MAP) and heart rate (HR) will be assessed. Adverse events such as bradycardia, nausea and vomiting  will  also be recorded. Data will be analysed with chi- square test and student-t test.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
65.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA 2 & 3 2.Aged between 65 – 80 yrs.

排除标准

  • 1.Patients with known cardiac abnormalities.
  • 2.Uncontrolled hypertension.
  • 3.Hyperthyroid patients.
  • 4.Coagulation or renal disorders.
  • 5.Infection at the site of spinal anaesthesia.

结局指标

主要结局

Prevention Of Spinal Hypotension

时间窗: heart rate and mean arterial blood pressure at Baseline, every 5 min for first half an hour, every 10 min for next 90 min

次要结局

  • Adverse events such as bradycardia, nausea and vomiting will be recorded(intra operative period and 6 hrs post operatively)

研究者

发起方
Dr Tharigonda Balaji
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Tharigonda Balaji

Government Medical College,Kadapa

研究点 (1)

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