To study the efficacy of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine & 0.5% Bupivacaine in the patients undergoing surgeries under subarachnoid block
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Onset, peak & level of Sensory block ( in seconds)
研究概览
简要总结
To evaluate and compare the analgesic effect of addition of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine and 0.5% Bupivacaine in the patients undergoing lower abdominal and lower limb surgeries under subarachnoid block and also to study the side effects and complications if any, intraoperatively as well as post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor 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
- •Consent from patients and ASA grading I-II posted for lower abdominal and lower limb surgical procedures planned under subarachnoid block.
排除标准
- •Non consenting as well pregnant patients, any spinal deformities, infection at the site,uncontrolled co-existing systemic and metabolic diseases, history of alcohol abuse, known sensivity to any LAAs and dexmedetomidine shall be excluded from the study , patients on beta blockers and sinus bradycardia.
结局指标
主要结局
Onset, peak & level of Sensory block ( in seconds)
时间窗: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Onset, peak & level of Motor block ( in seconds)
时间窗: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Total duration of Analgesia (in minutes)
时间窗: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Time for rescue Analgesia (in minutes)
时间窗: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Total doses & amount (in mg ) of rescue analgesia
时间窗: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2)
时间窗: Onset, peak & level of Sensory block ( in seconds) | Onset, peak & level of Motor block ( in seconds) | Total duration of Analgesia (in minutes) | Time for rescue Analgesia (in minutes) | Total doses & amount (in mg ) of rescue analgesia | Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes
次要结局
- To find out side effects & complications, if any.(VAS monitoring continued every 6 hours for next 24 hours.)