COMPARISON OF EFFECT OF IV FENTANYL VS IV DEXMEDETOMIDINE ON CHARACTERISTICS OF SPINAL ANAESTHESIA
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to achieve sensory blockade at T10, Time to achieve complete motor block, Highest level of sensory blockade achieved, Intraoperative hemodynamic parameters, Ramsay sedation score, Regression of spinal anaesthesia by two segments
研究概览
简要总结
It is a prospective, randomized, double blind, comparitive study. It is to study the effect of intravenous Fentanyl ( 1 mcg/kg ) vs intravenous Dexmedetomidine ( 0.5 mcg/kg) on characteristics of spinal anaesthesia to observe and compare the following parameters:
-
Time to achieve sensory blockade at T10
-
Time to achieve complete motor block
-
Highest level of sensory blockade achieved
-
Intraoperative hemodynamic parameters
-
Ramsay sedation score
-
Regression of Spinal Anaesthesia by two segments
-
Time to first rescue analgesia ( Duration of analgesia )
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I or II fit patients.
- •Ages between 18 and 65 years of either gender.
- •Patients posted for infra umbilical surgery under sub-arachnoid block.
- •Availability of informed consent.
排除标准
- •Patients with ASA physical status III or more.
- •Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic disease or with coagulation abnormalities.
- •Patients with contraindication for spinal anaesthesia.
- •Patients with known allergies to the study drug.
- •Patient refusal.
- •Patients below 18 years and above 65 years of age.
结局指标
主要结局
Time to achieve sensory blockade at T10, Time to achieve complete motor block, Highest level of sensory blockade achieved, Intraoperative hemodynamic parameters, Ramsay sedation score, Regression of spinal anaesthesia by two segments
时间窗: Basic vital parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, oxygen saturation & Ramsay sedation score will be recorded. Then, these will be recorded after dural puncture & every 5 min for 15 min & then every 15 min interval till the end of surgery after spinal anaesthesia.
次要结局
- Time of requirement of the first dose of postoperative rescue analgesic(1 hour, 2 hour, 4 hour, 8 hour, 12 hour & 24 hour after administration of Sub Arachnoid Block)