The Effect of low-dose Dexmedetomidine premedication on induction dose of Propofol under BIS monitoring in laparoscopic cholecystectomy: a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The induction dose of propofol after low dose dexmedetomidine premedication
研究概览
简要总结
Aim of the study is to study the effect of premedication with low dose dexmedetomidine on the induction dose of propofol in elective laparoscopic cholecystectomy
Eighty patients will be enrolled for this study after inclusion and exclusion criteria
They will be randomly allocated into two groups
Written informed consent will be taken from the patients
Group D will receive 0.5 mcg/kg Dexmedetomidine IV along with 2 mcg/cc fentanyl IV followed by general anaesthesia and group C will receive normal saline infusion IV along with 2 mcg/cc fentanyl IV followed by general anaesthesia
Heart rate, Mean Arterial Pressure, SpO2 and Bispectral Index will be noted at baseline , 5 and 10 minutes after stating dexmedetomidine infusion and at loss of verbal response, at intubation and post intubation at 3,6,9,12,15 minutes
Anaesthesia will be induced in both groups with propofol till loss of verbal response and induction dose requirement of propofol in milligrams will be noted
After completion of the surgical procedure and emergence from anaesthesia, pateint will be transferred to the post anesthesia recovery room
Patient in both groups will be given IV Paracetamol six hourly for pain relief post surgery
Patient will be assessed for pain using Numeric Pain Scale at 1,2,4,6 and 24 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor 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 and grade II Laparoscopic cholecystectomy.
排除标准
- •Preoperative heart rate less than 60 beats per minute Rhythm disturbances Pregnancy Allergic to Propofol or alpha 2 agonist.
结局指标
主要结局
The induction dose of propofol after low dose dexmedetomidine premedication
时间窗: At induction- 3 minutes after stopping dexmedetomidine infusion(at loss of verbal response)
次要结局
- The changes in BIS value at induction
- The hemodynamic response to intubation
- Total intraoperative requirement of analgesics(Fentanyl)(during intraoperative period)
- Post operative pain scores(NRS)(Post operative period at 1, 2, 4, 6, 24 hours)
- Side effects, if any(Intraoperatively and post operatively)
研究者
Dr Sharon Chacko
Employees State Insurance - Post Graduate Institute of Medical Sciences and Research, Basaidarapur