Comparison of Two Different Doses of Dexmedetomidine Added to Lignocaine in Patients Posted for Upper Limb Orthopedic Surgery Under Intravenous Regional Anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- hollmen scale
研究概览
简要总结
A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,
详细描述
After obtaining approval of the medical and ethical committee of Menoufia University & Nasser Institute for Research and Treatment, an informed and written consent from the patients, a prospective controlled randomized double blinded study will be performed
Sample size:
MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 80% with α error 5%, According to a previous study (13), showed that the duration of tourniquet time in group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value >0.05, while Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is success in the group B compared to group A, but there is no difference. So it can be relied upon in this study, based on this assumption, sample size was calculated according to these values produced a minimal samples size of 86 cases were enough to find such a difference. Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three groups 30 cases in each group. Patients will be randomly categorized into three equal groups (30 patients each): The patients will be randomly allocated to one of these three groups, using a computer-generated sequence of random numbers and a sealed envelope technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of ASA class I and II.
- •Patients of either sex.
- •Patients aged between 20-70 years.
- •Patients scheduled for forearm and hand surgery lasting for about 60 minutes.
排除标准
- •Patient with known hypersensitivity to any study medications.
- •Patient with Severe peripheral vascular disease and neurological disease.
- •Where use of tourniquet will be either not possible or contraindicated.
- •Patient with Hemolytic diathesis specially sickle cell anemia, epilepsy, diabetes mellitus, hypertension, cardiovascular disease like myocardial infarction, cardiac arrhythmias, heart block and altered mentation.
- •Procedures lasting for more than 90 min will be also not considered.
- •Therapy with adrenergic receptor antagonist, calcium channel blocker and ACE inhibitors.
- •Patient with impaired liver function.
研究组 & 干预措施
Group I
Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) alone diluted with normal saline 0.9% to make the final volume 30 ml
干预措施: Lidocaine IV (Drug)
Group II
Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.25 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml.
干预措施: Dexmedetomidine Injectable Solution [Dexdomitor] (Drug)
Group II
Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.25 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml.
干预措施: Lidocaine IV (Drug)
Group III
Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.5 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml
干预措施: Dexmedetomidine Injectable Solution [Dexdomitor] (Drug)
Group III
Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.5 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml
干预措施: Lidocaine IV (Drug)
结局指标
主要结局
hollmen scale
时间窗: 2 hours
change from base line for the scale (scale from 1 to 4)
modified bromage scale
时间窗: 2 hours
change from baseline for the scale (scale from 0 to 4 )
次要结局
- ramsey sedation score(2 hours)
- visual analogue score(2 hours)
研究者
mostafa saieed fahim mansour
doctor
Menoufia University