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临床试验/CTRI/2019/01/017309
CTRI/2019/01/017309已完成不适用

A study to compare the anaesthetic properties of 0.5% Ropivacaine alone and in combination with Dexmedetomidine for ultrasound guided Supraclavicular brachial plexus block in patients undergoing upper limb surgery.

JLN MEDICAL COLLEGE AJMER1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
To assess and compare the onset, duration and highest grade of sensory block.

研究概览

简要总结

The aim of the study is to compare anaesthetic properties of 0.5% isobaric Ropivacaine alone and in combination with Dexmedetomidine in ultrasound guided Supraclavicular Brachial Plexus Block in upper limb surgeries in the terms of:-

PRIMARY OBJECTIVES:

To assess and compare the onset, duration and highest grade of sensory block.

To assess and compare the onset, duration and highest grade of motor block.

To assess and compare the total duration of effective analgesia by visual analog scale (VAS).

To assess and compare the peri-operative sedation Score.

SECONDARY OBJECTIVES:

  1. To assess and compare the quality of anaesthesia.

  2. To assess and compare the hemodynamic changes if any.

  3. To assess and compare the proportion of patient having adverse

effects and any other complications.

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 and Investigator Blinded

入排标准

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

入选标准

  • Age group between 15 and 65 years.
  • Body weight 30 to 80 kg.
  • Patients belonging to ASA (American Society of Anaesthesiologists) class-I and II.
  • Patients undergoing upper limb surgeries of duration 1-2 hours in theatre with haemoglobin at least 9 gm/dl.
  • Patient free from any associated acute or chronic systemic illness.

排除标准

  • Patients not willing to participate in the study.
  • Uncooperative patients.
  • Patient with chronic pain or on long-term analgesics.
  • Any known hypersensitivity or contraindication to ropivacaine, dexmedetomidine.
  • Local pathology at the site of injection or disability limiting the performance of block.
  • Patients receiving beta blockers or cardiac drugs.
  • History of convulsion, allergy to the drug used, bleeding disorder, severe neurological deficit, thyroid disorder.
  • Patient with history of respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
  • Patients having a history of significant neurological, psychiatric, or neuromuscular disorders.
  • Pregnant, lactating mothers.
  • Inadequate block necessitating institution of general anaesthesia for continuation of surgical procedure.

结局指标

主要结局

To assess and compare the onset, duration and highest grade of sensory block.

时间窗: Duration of study is around 1 year.

To assess and compare the onset, duration and highest grade of motor block.

时间窗: Duration of study is around 1 year.

To assess and compare the total duration of effective analgesia by visual analog scale (VAS).

时间窗: Duration of study is around 1 year.

To assess and compare the peri-operative sedation Score.

时间窗: Duration of study is around 1 year.

次要结局

  • To assess and compare the quality of anaesthesia.(2. To assess and compare the hemodynamic changes if any.)

研究者

发起方
JLN MEDICAL COLLEGE AJMER
申办方类型
Government medical college

研究点 (1)

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