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临床试验/CTRI/2022/10/046588
CTRI/2022/10/046588尚未招募不适用

Comparison of intrathecal 0.5% hyperbaric bupivacaine plus fentanyl with 0.75% hyperbaric ropivacaine plus fentanyl in lower limb and lower abdominal surgeries

ESIC Medical College and PGIMSR KK Nagar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Comparison of the duration of motor block between the two drugs

研究概览

简要总结

Bupivacaine, is an amino-amide compound, was synthesized and introduced into the clinical practice in 1963 and proved to be a very effective long-acting local anaesthetic agent. In 1979, Albright drew attention to the dangers of the longer acting local anaesthetic agents, bupivacaine and etidocaine, in case they gained accidental intravascular access, resulting in re-entrant arrhythmias and cardiac depression, sometimes culminating in cardiac arrest. These shortcomings, of this otherwise novel local anaesthetic, resulted in the development of a newer anaesthetic agent ropivacaine.

Ropivacaine and levobupivacaine a new amino-amide local anaesthetic agents, are similar in chemical structure to bupivacaine. Extensive clinical data has shown that ropivacaine is effective and produces hemodynamic stability for regional anaesthetic techniques such as epidural and brachial plexus block.

Adjutants like opioids have shown to improve the analgesic duration of post spinal anaesthesia because of their motor sparing property thereby improving the quality and success of anaesthesia. Fentanyl is the most common opioid which is extensively used as an adjuvant to hyperbaric bupivacaine for enhancement of analgesia without increasing the depth of motor and sympathetic block.

Hyperbaric ropivacaine with fentanyl has been little studied in intrathecal anaesthesia However, this hyperbaric ropivacaine were isobaric preparations. Due to that the spread of drugs could not be controlled by adjusting the positions. Currently ropivacaine has been introduced as a hyperbaric ropivacaine. Studies comparing hyperbaric ropivacaine with other drugs are very few

Hyperbaric Ropivacaine molecule drug was launched by Neon laboratories first in india followed by other countries on 12.11.2021. No other manufactures available till now for this drug. So, the drug which was used by the previous studies was not hyperbaric ropivacaine. They have used isobaric ropivacaine and mixed with dextrose which is not a original drug molecule used by us.

This hyperbaric ropivacaine molecule which we have used in the original molecule by the manufacture which is approved by DGCI on 13.08.2021.

Only one or two studies carried out in Indian Population they rest or done in western countries. The results from this study will be more valid and relevant to practising anaesthesiologists who will have access to this DGCI approved Hyperbaric Ropivacaine. This can be compared with the previous studies to see if the results are same or different.

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Hence this study is conceptualized to compare the effects of block characterises such as duration of action and hemodynamic stability of hyperbaric ropivacaine plus fentanyl in spinal anaesthesia and to compare it with hyperbaric bupivacaine plus fentanyl in lower limb and lower abdominal surgeries.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1Patient with written informed consent 2ASA physical status of I and II 3Patient Posted for lower limb and lower abdominal surgeries 4Age groups 18- 60 years.

排除标准

  • 1Patient refusal 2Known allergy to local anaesthetics 3Gross spinal deformities 4Pregnancy and Lactating females 5Contraindications to regional anaesthesia (bleeding diathesis, use of any anti-coagulants, infection at the site of injection).

结局指标

主要结局

Comparison of the duration of motor block between the two drugs

时间窗: At 2 hours, 3 hours,4 hours,5 hours,6 hours

次要结局

  • Time to onset of sensory block(Every 1 min)
  • Duration of sensory block(Every 15 min)
  • Time of motor block(Every 15 min)
  • Hemodynamic parameters(Every 15min)

研究者

发起方
ESIC Medical College and PGIMSR KK Nagar
申办方类型
Government medical college

研究点 (1)

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