Comparison of the efficacy of fentanyl and dexmedetomidine as adjuvants to intrathecal 2-chloroprocaine for elective lower limb orthopaedic surgeries- a prospective, randomized, double blind study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
This study is to compare the efficacy of fentanyl and dexmedetomidine as an adjuvants to intrathecal 2-chloroprocaine among the patients posted for elective lower limb orthopaedic surgeries.
4ml of 2-chloroprocaine is the study drug in which 25 mcg of preservative free fentanyl is added as an adjuvant in one group and 5 mcg of dexmedetomidine is added in another group.
Study ends when patient complains pain after giving the drug.
onset,duration of sensory and motor block ,height of the sensory block, regression time of L1 dermatome is studied.
Visual Analog Scale(VAS), and Visual analogue Scale of patient satisfaction (VAS scores of patient satisfaction) is used to assess the pain and satisfaction at the drug in patient.
Adverse effects of the study drugs will be studied and manageed during study period .
Our study intends to prove that 2-chloroprocane can be used by adding adjuvants such as fentanyl and dexmedetomidine in short duration lower limb orthopaedic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of American society of Anesthesiologists physical status grade 1 and 2
- •Patients of age group between 20 to 65 years
- •patients posted for elective lower limb orthopaedic surgeries with duration of 1.5 to 2 hrs.
排除标准
- •Patients who are not willing to participate in the study.
- •Patients who do not give consent for spinal anaesthesia.
- •H/o spinal surgeries.
- •H/o coagulation and bleeding disorders.
- •Local site infections.
- •H/o hypersensitivity to study drugs.
- •H/o uncontrolled HTN and DM & H/o CAD.
- •Increased serum creatinine and liver enzymes: 2-3 times of normal.
- •H/o neuropsychiatric disorders and communication problems
- •Patients who cannot understand visual analog scale (VAS) measurements.
- •Pregnant women and lactating mothers.
- •Height-<140 cm & BMI > 35 Kg/m2.
结局指标
主要结局
Duration of analgesia
时间窗: Time of the first analgesic request
次要结局
- 1.Onset of sensory block(2.Onset of motor block)