Effect of intrathecal Dexmedetomidine as an adjuvant to hyperbaric bupivacaine in orthopaedic lower limb surgery: An Intervention Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- motor block regression in bromage score,sensory block regression by pin prick sensation
研究概览
简要总结
Dexmedetomidine is an alpha-2 adrenergic receptor agonist recently introduced in indian market.
It has been used as an adjunct to spinal and general anaesthesia and for sedation in intensive care unit.
The aim of present study is to evaluate the efficacy of dexmedetomidine as an adjunct to bupivacaine in subarachnoid block.
Study will be carried out in 50 ASA physical status I and II, aged 18 to 65 years going to undergo lower limb orthopaedic surgery. Patients will be randomly allocated into 2 groups, each of 25 by computer generated random number table. 1st group will be given bupivacaine and 2nd group will be given bupivacaine + dexmedetomidine in subarachnoid space. Patients will be assessed for onset and duration of sensory and motor block produced by both groups.
Analgesia, hemodynamic variables and complications will be recorded intraoperatively. Patients will be observed for 6 hours postoperatively. Data will be expressed as mean and standard deviation or numbers and percentages as
applicable. Comparison between two groups will be done using unpaired t test for quantitative data and chi square test for qualitative data. p value <0.05 will be considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
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.Age 18 to 65 years 2.Both genders 3.ASA grade I and II.
排除标准
- •1.History of spine surgery, hepatic failure, neuromuscular disorders 2.chronic history of headache, backache and infection in back 3.Any absolute or relative contraindication to study drug 4.Uncooperative patients 5.Coagulopathy 6.Patient with history of cardiac or respiratory diseases.
结局指标
主要结局
motor block regression in bromage score,sensory block regression by pin prick sensation
时间窗: 6 to 8 hours after intrathecal injection
次要结局
- Onset of Sensory and motor block, Hemodynamic alterations,(Numeric Rating Scale 6 hours after surgery.)