Comparative evaluation of Dexmedetomidine-Ketamine versus Ketamine-Propofol for sedation and analgesia in patients undergoing Dilation and Curettage: A prospective randomized double blind study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3)
研究概览
简要总结
Informed consent willbe taken from each patient willing to participate in the study. They will be allocated to one of the following two groupsas per randomization. GroupDK(n=40): will receive inj dexmedetomidine (0.5 mic/kg)and ketamine (1 mg/kg) and GroupKP (n=40) : will receive inj ketamine 1mg/kg and propofol1 mg/kg diluted to total volume of 10 ml before beginning the procedure overthe period of 2 minutes. Time is recorded to achieve RSS score of 6 that will indicate onset ofsedation. Patients are then placed inlithotomy position and procedure is started. After completion of procedure patient is again made supine and time isrecorded till patients achieve RSS 3, and then shifted to post op area. RSS andhemodynamic parameters, Spo2 and RR are monitored every 5 min. If sedationscore is <6 then inj. Ketamine 0.5mg/kg is given as rescue drug for sedationand analgesia.
In post op area patients are shifted to ward as perAlderete criteria >9.
Duration of analgesia will be recorded for both groupsand inj diclofenac 75 mg will be used as rescue analgesia if VAS>3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients of abnormal uterine bleeding scheduled for elective endometrial sampling American Society of Anaesthesiology I and II.
排除标准
- •History of cardiovascular diseases e.g. ischemic heart disease, conduction defects, etc.
- •History of compromised renal / hepatic / neuronal functions.
- •Uncontrolled Hypertension and Diabetes History of alcohol, substance abuse, chronic use of analgesic and sedatives, psychiatric disorders •Patients on beta blocker or having persistent bradycardia with HR<
- •â€¢Drug allergy •Procedure lasting for >30 min.
- •â€¢Any surgical complications during D& C e.g. uterine perforation, excessive bleeding etc.
- •â€¢Viable Pregnancy, acute PID, undiagnosed genital tract bleeding, mass in vagina or cervix, severe arthritis hip bone, bleeding disorders, virgin females.
结局指标
主要结局
Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3)
时间窗: Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3)
次要结局
- 1.Intraoperative Haemodynamics (Heart Rate, Blood Pressure, Spo2, Respiratory rate)(2.Post op recovery score ( Modified Aldrete Score))