A randomizrd double blind clinical trial to compare dexmedetomidine with fentanyl as an anesthetic adjuvant in patients undergoing ENT surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To Study and compare the effects of dexmedetomidine with fentanyl for
研究概览
简要总结
This study is a randomized, double blind, parallel group, active control trial comparing dexmedetomidine with fantanyl as an anesthetic adjuvants in patients undergoing ENT surgery. The study will be conducted to compare the sympatholytic effects and intraoperative hemodynamics and recovery parameters of dexmedetomidine with fentanyl. Both group will receive study drug bolus infusion (Dexmed group 1microgram/kg, Fentanyl group 2microgram/kg)(over 10 minutes followed by maintenance dose (Dexmed group 0.6microgram/kg/hr, Fentanyl group 1microgram/kg/hr)infusion. Patient will be induced with injection propofol 2-3 mg/kg i.v and rocuronium 0.9 mg/kg I.v. Patient will be maintain on oxygen, nitrous oxide, vecuronium intermittently and propofol infusion(75microgram/kg/min). The hemodynamic parameters and recovery variables Will be recorded at specific time interval.
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
- •A) ASA class 1&2 scheduled for elective surgeries.
- •B) age between 18 & 60 years.
- •C) no history of alcohol or drug abuse.
- •D) not received any opioid analgesic or alpha 2 agonist 24 hours prior to surgery.
排除标准
- •A)history of allergy to alpha agonist or sulpha drug.
- •B)pregnant, lactating mothers and morbidly obese patients.
- •C)heart block.
- •D)presence of clinically significant neurologic, cardiac,renal,hepatic,gastrointestinal endocrine disease.
结局指标
主要结局
To Study and compare the effects of dexmedetomidine with fentanyl for
时间窗: Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
1) The sympatholytic effects & intraoperative hemodynamics.
时间窗: Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
2) Reduction in intraoperative propofol requirement.
时间窗: Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
3) The recovery variables.
时间窗: Heamodynamics parameters observed intraoperatively and recovery variables during extubation.
次要结局
- To compare analgesic sparing effects and postoperative nausea and vomiting of dexmedetomidine with fentanyl.(Secondary outcome observed after extubation for one hour.)