A Prospective Randomized Study Comparing Intrathecal Dexmedetomidine and Fentanyl as Adjuvants to Hyperbaric Ropivacaine in Infra Umbilical Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Onset of sensory blockade
研究概览
简要总结
Spinal anesthesia is the most preferred technique for infraumbilical surgeries. Hyperbaric Ropivacaine has been shown to produce reliable and predictable anesthesia for surgery. Fentanyl, a synthetic lipophilic opioid, and Dexmedetomidine, a new highly selective alpha 2 agonist have been used as neuraxial adjuvants in spinal anesthesia to prolong intraoperative and postoperative analgesia. This study is undertaken to investigate and compare the clinical effects of 0.75% hyperbaric ropivacaine with additives such as fentanyl and dexmedetomidine on spinal anesthesia for infraumbilical surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to ASA physical status Class I and Class Patients without any severe comorbid diseases.
排除标准
- •Patients having any absolute contraindications for spinal anesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis, local infection and cardiac, respiratory, and CNS diseases are excluded from the study Pregnant females.
- •chronic diseases such as diabetes and hypertension Patients with body mass index >30 kg/m2 Patients shorter than 150 cm.
结局指标
主要结局
Onset of sensory blockade
时间窗: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Maximum level of sensory blockade attained and the time taken for the same
时间窗: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Time for two-segment sensory regression
时间窗: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Onset and duration of motor blockade
时间窗: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
Total duration of analgesia
时间窗: 1min, 2min, 3min, 4min, 5min, 6min, 7min, 8min, 9min, 10min, 30min, 60min, 90min, 120min, 150min, 180min, 210min, 240min, 270min, 300min, 330min, 360min
次要结局
- Hemodynamic changes, Adverse Effects(5min, 10min, 15min, 20min, 25min, 30min, 35min, 40min, 45min, 50min, 55min, 60min)