A clinical comparative study of dexmedetomidine , fentanyl , buprenorphine as adjuvants to intrathecal bupivacaine in lower limb surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To note the time duration of sensory and motor block of the intervention and 2 comparator agents
研究概览
简要总结
Patients will be selected from elective OT register . Patient will be assessed for eligibility criteria and will be randomly allocated into three groups based on computer generated randomisation. Consent will be taken and patient will be shifted inside OT . Baseline vitals will be noted and IV line will be secured . Under strict aseptic precautions , subarachnoid block will be performed with 25 gauze quincke needle in L3 to L4 interspace. Loaded drug will be given in 10 to 15 seconds after attainment of free flow of CSF . Time taken to attain sensory block till T10 and maximum sensory block attained will be noted. Motor block will be noted via Bromage scale and time taken to attain scale 3 will be noted. Intra operative vitals like heart rate , blood pressure , oxygen saturation will be assessed and any adverse effects will be treated accordingly .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Age 18 to 60 yrs , male and female .
- •Patients of American Society of Anaesthesiologists physical status class 1 and class
- •Patients scheduled for elective lower limb surgeries.
排除标准
- •BMI more than 35 kg per meter square
- •Patients with bleeding disorders or patients on anticoagulant therapy
- •Patients with history of cardiac disorders or are on beta blockers or alpha antagonists .
- •Any allergy to test drug
- •Pregnancy and lactation 6.Patients with chronic pain on slow-release preparations of opioid, drug abuse or chronic alcohol use .
- •Patients with dementia or cognitive problems.
- •Any contraindications to spinal anaesthesia.
结局指标
主要结局
To note the time duration of sensory and motor block of the intervention and 2 comparator agents
时间窗: Intraoperative and postoperative
次要结局
- To note the adverse effects like bradycardia , hypotension , nausea , vomiting , itching , respiratory depression , desaturation(Intraoperative)
- To assess the duration of postoperative analgesia(Postoperative)
- To monitor heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressure , oxygen saturation(Intraoperative)
研究者
Subhajyoti konar
Dr. B R Ambedkar medical college and hospital