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临床试验/CTRI/2024/02/063018
CTRI/2024/02/063018已完成3 期

A Randomized Comparative Study to Evaluate the Effects of Successional Versus Premixed Administration of Intrathecal Hyperbaric Ropivacaine 0.75% and Fentanyl in patients scheduled for Elective Urological Surgery Under Spinal Anaesthesia

Dr Sapna Bansal Professor Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
To study the onset ,duration and highest level of sensory block along with degree and duration of motor block

研究概览

简要总结

Now a days, spinal anaesthesia is being utilized in many operations which are below the umbilicus as being cost effective, associated with few respiratory complications, the airway is not manipulated which reduces the risk of airway obstruction or aspiration of gastric components, blood loss is less intraoperatively comparative to same operation being conducted under general anaesthesia. The introduction of Hyperbaric Ropivacaine (0.75%) has revolutionized the safety profile of local anaesthetic agents. Ropivacaine is the pure S-enantiomer which is associated decreased cardiotoxicity as compared to Bupivacaine. Other advantages of Ropivacaine are that it produces sensorimotor differential blockade with early recovery from motor blockade and thus leading to early ambulation of patient and also has decreased central nervous system toxicity.  Blending opioids with hyperbaric bupivacaine affects the amount of drug that spreads into the intrathecal space because it changes the density of the hyperbaric solution.

. At 37°C, cerebrospinal fluid (CSF) has a density of 1.00059 g/ml. Fentanyl has a baricity of 0.99410 while hyperbaric bupivacaine has a baricity of 1.02360. After annexing Fentanyl(20mcg) to the identical syringe as local anaesthetic, baricity of the solution becomes 1.018502. A change in a solution’s baricity of 0.0006 can change how local anaesthesia spreads in the cerebrospinal fluid (CSF). Hyperbaric solutions improve intraoperative physiological state, lengthen the period of impact, and become more easy to predict, with greater unfold within the direction of gravity and less inter-patient variability, provide with stable haemodynamic and prolonged postoperative analgesia. [15] The specific gravity of Ropivacaine hydrochloride in dextrose injection is between 1.025 and 1.035 at 250 C and about 1.03 at 370 C which is more comparative to Bupivacaine. Though the Fentanyl has been used extensively premixed with hyperbaric bupivacaine for spinal anaesthesia, there is paucity of literature on clinical effects and understanding of mechanism of influence of fentanyl on subarachnoid block produced by hyperbaric ropivacaine when administered separately by another syringe, either before or after ropivacaine. Correlating with the available literatures on premixed versus sequential administration of intrathecal fentanyl and bupivacaine - The present study will be done to evaluate the effects of successional versus premixed administration of intrathecal hyperbaric ropivacaine and fentanyl in spinal anaesthesia undergoing elective urological surgery.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • either gender of age 18-55years and ASA I and ASA II status scheduled for elective urological surgery under spinal anaesthesia.

排除标准

  • Negative consent by the patient
  • contraindication for spinal anaesthesia ( such as coagulopathy, infection at injection site, hypotension ,disease or deformity of spine) 3.psychiatric patient
  • ASA status III/IV
  • known sensitivity to drug.

结局指标

主要结局

To study the onset ,duration and highest level of sensory block along with degree and duration of motor block

时间窗: intraoperative period after spinal anaesthesia

次要结局

  • To study the hemodynamic changes occuring among the two study groups after administration of the respective drugs

研究者

发起方
Dr Sapna Bansal Professor Department of Anaesthesiology
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Tania Ghosh

Maharishi Markandeshwar university

研究点 (1)

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