跳至主要内容
临床试验/CTRI/2018/02/011923
CTRI/2018/02/011923已完成Unknown

To study the effects of dexmedetomidine in two different doses as an adjunct to Ropivacaine in epidural for hip surgeries: A randomized controlled study

Dr Rajendra Prasad Government Medical College1 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23日最近更新:

试验速览

阶段
Unknown
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 postoperative analgesia

研究概览

简要总结

Post oprative pain management is of growing concern in current practice of anesthesia as inadequately controlled postoperative paincan  led  to  higher incidence of chronic post surgical pain, increased stress response, decreased ambulation and increased incidnces of thrombo embolism,  postoperative morbidities and worsened patient releted outcomes such as increased hospital stay, poor quality of life.

Among the commonly used postop-analgesia methods, patient controlled analgesia (PCA) with opioids, non-steroidal anti-inflammatory drugs (NSAIDS) and epidural LA, epidural LA with adjuncts are the most effective as they provide  dynamic pain relief after hip surgeries. Intrathecal and epidural route of administration has an advantage that an analgesic can be administered at the time of giving block with a single injection, which is being utilised for providing anaesthesia for surgery as well as for postoperative pain relief, thereby serving a dual purpose of anaesthesia and postoperative analgesia.

Many adjuncts to local anaesthetics have been Used to  supplement epidural local anaesthetics for improving and enhancing the quality and duration of anaesthesia, reducing the  total dose of local anaesthetics and their side effects, increasing the duration of postoperative analgesia and reduced postoperative analgesic requirements.  Adjunct used  commonly in central neuraxial blocks are opioids which offer the above mentioned   advantagesbut with side effects like delayed respiratory depression, nausea, vomiting, pruritus, constipation & urinary retention

Torben et al examined the dose-response relationship of epidural clonidine at small doses (75 mcg) with respect to prolonging bupivacaine epidural anaesthesia and pain relief. They concluded that small doses of epidural clonidine (75 mcg followed by 18.75 mcg/hr infusion) significantly prolong the anaesthetic and analgesic effects of bupivacaine in a dose-dependent manner without unwarranted side effects like excessive sedation, hypotension and bradycardia

Antônio et al concluded that 150 mcg clonidine and 2 mcg/kg dexmedetomidine when added to 0.75%ropivacaine epidurally in cholecystectomy procedures hastened the onset of sensory and motor block and prolonged the duration of the block produced in comparison to the use of ropivacaine alone.

Bajwa SS et alfound that 1.5 mcg/kg dexmedetomidine and 2 mcg /kg clonidine  epidurally when added to 0.75% ropivacaine in patients undergoing vaginal hysterectomies, dexmedetomidine produced significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than ropivacaine with clonidine without serious side effects.

In another study Bajwa SS et al added 1 mcg/kg dexmedetomidine to 0.75% ropivacaine epidurally which produced prolonged motor and sensory block as compared with addition of 1 mcg/kg fentanyl with ropivacaine in lower limb orthopaedic surgeries.

These reviews, aim to give background information to explore the properties and applications of the alpha2-adrenoceptor agonist, and optimal dose of dexmedetomidine epidurally with less worrysome side effects in patients of hip surgeries

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA Class I-III, Undergoing Hip Surgeries.

排除标准

  • 1.Patient’s refusal for the block.
  • 2.Uncontrolled and labile hypertension.
  • 3.Patients using alpha2-adrenergic receptors antagonists 4.Patients noted to have dysrhythmias on the electrocardiogram (ECG).
  • 5.Allergic to study drugs.
  • 6.Absolute contraindication for spinal or epidural anaesthesia.

结局指标

主要结局

To study and compare the duration of postoperative analgesia

时间窗: Base line | 1Min | 5 Min | 10 Min | 15 Min | 20 Min | 25 Min | 30 Min | 40 Min | 50 Min | 60 Min | 75 Min | 90 Min | 105 Min | 120 Min | 180 Min | 240 Min | 300 Min | 360 Min | 8th hour | 10th hour | 12th hour | 15th hour | 18th hour | 24th hour

次要结局

  • study and compare effects on haemodynamic stability, sedation, respiration(Base line)

研究者

申办方类型
Government medical college

研究点 (1)

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