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临床试验/CTRI/2023/02/050078
CTRI/2023/02/050078尚未招募4 期

A Comparative study between two different doses of Dexmedetomidine as adjuvant to 0.5 % Levobupivacaine in ultrasound guided supraclavicular brachial plexus block.

MGM Medical College and Hospital Aurangabad1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年2月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
1)Heart rate

研究概览

简要总结

Brachial plexus block has evolved into an excellent substitute to general anaesthesia for upper limb surgeries. It curtails the stress response and using minimal anaesthetic drugs  it provides  intraoperative analgesia with prolonged post operative pain relief. Among the various upper limb blockades, supraclavicular brachial plexus block (SCBP) is considered as ’spinal of arm’.

Brachial plexus block is a peripheral block commonly used for upper limb surgery. Ultrasound guided supraclavicular brachial plexus block facilitate more accurate and effective method of drug administration.

Levobupivacaine is used for this study as it has advantages of long acting and less cardiotoxic and neurotoxic. Levobupivacaine has  recently been used more for supraclavicular brachial plexus block due to the above mentioned advantages.

The idea behind using an adjuvant with local anaesthetic is to reduce the requirement of analgesics in post operative period.

Various adjuvants have been studied for prolonging the effect of supraclavicular blocks(4). Alpha 2 adrenoreceptor agonist such as clonidine and dexmedetomidine are the two most commonly used drugs. They have shown sedation, analgesia, sympatholysis,cardiac stabilization and anaesthetic sparing properties. Out of these dexmedetomidine an imidazole compoind is more selective than clonidine(eight times).Dexmedetomidine causes analgesia by its action at supraspinal (locus coeruleus) or at spinal level or even at peripheral Alpha 2 receptors by the reduction of transmission of nociceptive stimulus.(2).

This study compares the effects of two different doses of dexmedetomidine as an adjuvant added to 0.5% Levobupivacaine. In our study we are using ultrasound guided technique for supraclavicular brachial plexus block.

In this study we hypothesise that two different doses of dexmedetomidine (0.5 & 1 microgram per kg) are equallyt effective.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Patients of ASA physical grade I –II 2.18-65 years of age 3.Both sexes 4.Posted for elective surgeries of midarm forearm and hand will be included.

排除标准

  • 1.Patient refusal 2.History of infection at site of block 3.Coagulopathies 4.Patients with known hypersensitivity to local anaesthetic or dexmedetomidine 5.Presence of 1st, 2nd or 3rd degree heart block 6.Pregnant women 7.Patients on beta blockers Pre-existing peripheral neuropathy.

结局指标

主要结局

1)Heart rate

时间窗: 1.Time at which procedure of giving block is finished. | 2)Five minute | 3)Ten minute | 3)Fifteen minute | 4)Twenty minute | 5)Fourty minute

3)Saturation

时间窗: 1.Time at which procedure of giving block is finished. | 2)Five minute | 3)Ten minute | 3)Fifteen minute | 4)Twenty minute | 5)Fourty minute

2)Mean arterial pressure

时间窗: 1.Time at which procedure of giving block is finished. | 2)Five minute | 3)Ten minute | 3)Fifteen minute | 4)Twenty minute | 5)Fourty minute

次要结局

  • 1.Heart rate(2.Mean arterial pressure)

研究者

发起方
MGM Medical College and Hospital Aurangabad
申办方类型
Private medical college

研究点 (1)

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