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临床试验/CTRI/2015/06/005866
CTRI/2015/06/005866已完成不适用

A COMPARATIVE STUDY OF MIDAZOLAM IN TWO DIFFERENT DOSES AS AN ADJUNCT TO LIGNOCAINE FOR ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCKA RANDOMISED CONTROLLED STUDY

Government of Himachal Pradesh1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年12月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
•To study and compare the duration of analgesia in three group of patients.

研究概览

简要总结

The present study was carried out on 90 patients, ASA I and II, aged between 18-60 years, scheduled for orthopedic upper extremity surgery under ultrasound guided supraclavicular brachial plexus block. The patients were randomly divided into three groups. Group L (n=30) received 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 5 ml of normal saline. Group M30 (n=30) received 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 30 µg/kg midazolam + normal saline (total volume 25 ml) and group M50 (n=30) received 20 ml of 1.5% Lignocaine with adrenaline (1:200000) + 50µg/kg midazolam + normal saline (total volume 25 ml).

The block effect was studied in the three groups for the onset of sensory and motor block, duration of sensory and motor block and the total duration of post operative analgesia. Quality of block was evaluated as partial/failed blocks among the three groups and Surgeon’s satisfaction score. The patients were also closely examined for any hemodynamic changes, sedation score and total number of rescue analgesics required in 24 hours.

研究设计

研究类型
Interventional
分配方式
Random Number Table

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Males and females between the age group 18-60 years.
  • ASA class I-II.
  • BMI 18.5-29.
  • Undergoing surgeries around elbow, forearm and hand.

排除标准

  • 1.Patients refusal for block.
  • 2.Patients having bleeding disorders.
  • 3.Local infection at the site where needle for block is to be inserted.
  • 4.Allergic to study drugs.
  • 5.Patients of head injury, renal disease, liver disease and cardiac disease.
  • 6.Patients in whom the block effect will be partial and will require supplementary anesthesia.

结局指标

主要结局

•To study and compare the duration of analgesia in three group of patients.

时间窗: duration of analgesia

次要结局

  • •To evaluate and compare the onset and duration of sensory and motor blockade with lignocaine with adrenaline (1: 200000) alone and with midazolam in two different doses.(•To find the optimal dose of midazolam as an adjunct for brachial plexus block and post-operative analgesia.)

研究者

申办方类型
Government medical college

研究点 (1)

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