A Randomized Controlled Study To Evaluate The Effects With Or Without Intravenous Dexmedetomidine As A Pre Medication On Sensory Block Induced By Spinal Anesthesia With 0.5 Percent Hyperbaric Bupivacaine In Lower Limb Surgeries SMS Medical College Jaipur
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean onset and duration of sensory blockade
研究概览
简要总结
Spinal anesthesia is a type of regional anesthesia which is commonly used technique for lower abdominal , lower limb surgeries. Spinal anesthesia with bupivacaine is the most preferred technique of anesthesia . Bupivacaine when used in recommended doses, under spinal anesthesia produces complete sensory and motor blockade. Various adjuvants like dexmedetomidine , opioids are added to enhance the effects of the local anesthetics .Dexmedetomidine potentiates the anesthetic effects of all intraoperative anesthetics, regardless of method of administration .Recent studies show that dexmedetomidine prolongs the sensory blockade induced by spinal anesthesia .
For this a total of 66 patients(n=66) undergoing lower limb surgeries will be randomly divided into two groups(Group A and Group B).Group A patients will receive 10 ml 0.9% normal saline as infusion over 10 minutes ,20 minutes prior to subarachnoid block with 15 mg 0.5% hyperbaric bupivacaine and Group B patients will receive 1mcg/kg body weight dexmedetomidine in 10 ml 0.9% normal saline as infusion over 10 minutes, 20 minutes prior to subarachnoid block.
Patient will be received in operation theatre , intravenous cannula will be secured and hemodynamic variables will be noted .Loading dose of intravenous dexmedetomidine and normal saline as per study group will be given.
Surgery will be started after T10 level sensory blockade is achieved. Quantitative values of time of onset and duration of sensory and motor blockade ,time taken for sensory regression and request of first rescue analgesia will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Written Informed Consent 2.Age group of 18 to 50 years 3.Both genders 4.Patients of ASA Grade I and II 5.Weight of Patient 50 to 90 kg 6.Patients undergoing lower limb surgeries 7.Height of Patient more than 150 cm.
排除标准
- •1.Patient with history of drug allergy to local anaesthestics 2.Patient with coagulation disorders or taking anticoagulant drugs 3.Patient on alpha 2 agonists and beta blockers 4.Patient with history of heart blocks ,heart rate less than 50 per minute and dysrhytmias 5.Patient with uncontrolled metabolic disease 6.Psychologically unstable patients with preexisting neurological deficits 7.Patient with Spinal Deformities 8.Patient not included in any other study.
结局指标
主要结局
Mean onset and duration of sensory blockade
时间窗: 1.0 min | 2.2 min | 3.4 min | 4.6 min | 5.8 min | 6.10 min | 7.25 min | 8.40 min | 9.55 min
次要结局
- Mean onset of motor blockade(minutes)(Mean duration of motor blockade(minutes))
研究者
Dr Shriphal Meena
Sawai Man Singh Medical College
