Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular Brachial Plexus Block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- This prospective and observational study will help us to compare the efficacy between Inj. Bupivacaine and Inj dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation
研究概览
简要总结
Subject: “Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular
Brachial Plexus Block”
AIM: To Comparative Evaluation of Dexmedetomidine and Dexamethasone as Adjuvants in Supraclavicular Brachial Plexus Block”
OBJECTIVES
1.To observe and compare Onset and duration of sensory and motor block
2.To observe and compare Duration of analgesia
3.To compare Perioperative hemodynamic changes & any adverse effects
MATERIAL AND METHODOLOGY
This will be a comparative double blinded randomized observational study in which after approval from institutional review board and informed written consent from the patient, study will be started.
All patients will be subjected to detailed pre anaesthetic evaluation with clinical history, general and systemic examination and all routine investigations like hemoglobin, RBS, RFT, LFT, serum electrolytes, X-ray, ECG and other specific investigations according to the patient’s clinical evaluation. Patients will be advised to keep NBM before Operation.
Pre-Operative vitals will be recorded.
An IV infusion of Ringer Lactate /Normal Saline will be started.
Study Design- randomized double blinded Study
Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by whichever is earlier.
Sample size:60s,2 group each divided in 30s
Group-1 :Patients who have received inj. Bupivacaine 0.5% 20 ml with inj. Dexmedetomidine 0.5 mcg/kg through PNS or USG machine guided supraclavicular block
Group-2: patients who have received inj. Bupivacaine 0.5% 20 ml with inj. dexomethasone (8mg) through PNS or USG machine guided supraclavicular block.
OBSERVATIONS :
-
OnsetofSensoryBlock
-
DurationofSensoryBlock
-
OnsetofMotorBlock
-
DurationofMotorBlock
-
DurationofAnalgesia:TimefromOnsetofsensoryblocktoneedforfirstrescueanalgesia.
-
Hemodynamic Parameters
-
SedationScore
-
PerioperativeComplications
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to sign inform consent.ASA grade I and II patients posted for elective upper limb surgeries.
排除标准
- •Patient refusal Infection at local site Hypersensitivity or Allergy to local anaesthetic agent Coagulation disorders Patient on Anticoagulants Alcoholic or patient with drug abuse Patients receiving any drug that interact with our study drug Pre Existing Nerve injury Inadequate effect of nerve block or supplemented with other type of anaesthesia.
结局指标
主要结局
This prospective and observational study will help us to compare the efficacy between Inj. Bupivacaine and Inj dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation
时间窗: This prospective and observational study will help us to compare the efficacy between inj Bupivacaine and Inj dexomethasone vs Inj Bupivacaine and Inj dexmedetomidine Improving the duration and Quality of analgesia, Reducing dose of bupivacaine so reduce toxicity, some provide sedation haemodynamic responses to anaesthesia by having better outcome in haemodynemics at baseline and fifteen minutes after inductuin up to one hour and than one hourly up to twenty four hours after surgery
次要结局
- Analgesia & haemodynamic responses to anaesthesia by having better outcome in haemodynemic(Twenty four hours after induction of local anaesthesia after surgery)
研究者
Paresh M Chaudhary
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre