Comparative evaluation of Dexmedetomidine-Ketamine versus Ketamine-Propofol for sedation and analgesia in cervical cancer patients for intra cavitary brachytherapy: A prospective randomized double blind study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Onset and recovery of sedation
研究概览
简要总结
Patients will be allocated to one of the following two groups as per randomization:.Group DK( 23): inj dexmedetomidine (0.5 mic/kg) and ketamine (1 mg/kg) and Group KP ( 23) : inj ketamine 1mg/kg and propofol 1 mg/kg diluted to total volume of 10 ml will be given before beginning the procedure over the period of 2 minutes. Time is recorded to achieve RSS
score of 6 that will indicate onset of sedation. Patients are then placed inlithotomy position and procedure is started which consists of dilation of cervical canal and insertion of applicators and adequate vaginal packing. After completion of procedure patient is again made supine and time is recorded till patients achieve RSS 3, and then shifted to post op area and followed for 6 hours post operatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 cervical cancer scheduled for elective brachytherapy Patients aged between 20-70 years ASA I, II.
排除标准
- •History of cardiovascular diseases e.g. ischaemic heart disease,conduction defects, etc.
- •History of compromised renal / hepatic / neuronal functions.
- •Uncontrolled hypertension and Diabetes Pregnant or lactating women.
- •History alcohol, substance abuse, chronic use of analgesic and sedatives, psychiatric disorders Patients on b blocker or having persistent bradycardia with HR30 min.
结局指标
主要结局
Onset and recovery of sedation
时间窗: Baseline, 1,2,5,7,10,15,20,25 and 30 minutes.
次要结局
- Intraoperative Haemodynamics (Heart(Rate,Blood Pressure, Spo2, Respiratory rate))
研究者
Dr Sakshi
Ananta institute of medical sciences