Effect on sensory block duration after spinal anesthesia supplemented with intravenous Dexamethasone.
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
- Sensory block duration
研究概览
简要总结
The randomised, doubleblind interventional study will be conducted in the Department of Anaesthesiology at AIIMS,Raipur. After obtaining approval from Institutional Ethics Committee, this study will beconducted for 18 months in 60 American Society of Anaesthesiologists(ASA) physical status I and II patients in the age group of 18–60 years posted for elective unilateral open inguinal hernia surgeries. Patients with a history of allergy to drugs used in the study, a history of substance abuse, with a body mass index (BMI) ≥35 and patients with psychosis/gross neurological disorders will be excluded. All the patients who meet the inclusion criteria will be enrolled in the study and written informed consent will be obtained for the participation in the study
All patients will be made to fast according to the standard nil per oral guidelines. The patients will be randomised into two groups by a computergenerated randomisation list to receive either of the two regimens. [Figure 1] For the BD group, 3 ml of 0.5% bupivacaine(heavy) with 8 mg of dexamethasone(2ml)IV and for the BS group 3 ml of 0.5% bupivacaine(heavy) with 2ml normal saline IV was administered to keep the total volume the same in both groups.
A doubleblinding technique will be followed, where an anaesthesiologist who is not part of the study will prepare the solution according to the allocated group. The solution will then be handed over to the investigator who will administer the spinal anaesthesia. The investigator will be unaware of the group allocation.
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) physical status I and II patients in the age group of 18–60 years posted for elective unilateral open inguinal hernia surgeries.
排除标准
- •Patients with a history of allergy to drugs used in the study, a history of substance abuse, with a body mass index (BMI) ≥35 and patients with psychosis/gross neurological disorders will be excluded.
结局指标
主要结局
Sensory block duration
时间窗: Intra-operative period
次要结局
- 1) To determine the time taken to achieve highest level of sensory block.(2) To determine Time required to first rescue analgesia.)
研究者
Dibyanshu Shekhar Swain
AIIMS Raipur
