Comparison of effects of different doses of dexmedetomidine as an intrathecal adjuvant to hyperbaric ropivacaine in lower abdominal surgeries : a prospective randomised controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.To asses onset and duration of sensory blockade from the time of drug adminitration
研究概览
简要总结
This is a prospective randomized controlled study to compare the effects of different doses of dexmedetomidine that is 5, 10, 15 and 20mcg as an intrathecal adjuvant to hyperbaric ropivacaine in elective lower abdominal surgeries. Total sample size id 100, divided into 5 groups including the control group. Primary objective is to asses the onset and duration of sensory blockade, time for 2 segment sensory regression, onset and duration of motor blockade and time of rescue analgesia. Secondary objective include monitoring of hemodynamics and adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All ASA Grade 1 and 2, patients scheduled for elective lower abdominal surgery under subarachnoid block.
排除标准
- •Patients with hypertension, diabetes, spinal deformity, coagulation disorder, drug allergy, cardiovascular , respiratory or neurological disorders, pregnant patients, height less than 140cm, BMI more than 30kg per meter square, impaired liver and renal function tests, ASA Grade 3, 4, local skin infections.
结局指标
主要结局
1.To asses onset and duration of sensory blockade from the time of drug adminitration
时间窗: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
2. Maximum sensory level achieved and time taken for it
时间窗: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
3.Time taken for 2 segment sensory regression
时间窗: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
4. Onset and duration of motor blockade
时间窗: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
5. Total duration of post op analgesia
时间窗: 1.To asses onset and duration of sensory blockade from the time of administration of drug | 2. Maximum sensory level achieved and time taken for it | 3.Time taken for 2 segment sensory regression | 4. Onset and duration of motor blockade | 5. Total duration of post op analgesia every hour till time of rescue analgesia. | Every outcome assessed every 30 seconds till 5 minutes, every 1 minuthe till next 10 minutes every 5 minutes till end of surgery
次要结局
- Changes in hemodynamic parameters and adverse effects(24 hours after spinal anaesthsia)
研究者
Simran Naval
Mysore Medical College and Research Institute