A comparative study to assess the efficacy between Ketamine-Propofol and Ketamine-Dexmedetomidine on sedation in surgical excision of breast fibroadenoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- to determine the efficacy between ketamine-propofol and dexmedetomidine- ketamine on adequate sedation using Ramsay sedation scale
研究概览
简要总结
This study is mainly aiming to study the efficacy of KETAMINE - DEXMEDETOMIDINE versus KETAMINE - PROPOFOL as sedation for fibroadenoma . KETAMINE - PROPOFOL is already established for sedation where as dexmedetomidine is a newly introduced drug . this is the first time comparison of these two drugs groups are being used in sedation for fibroadenoma. Hoping this study will help in switch to newer, much safer drugs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •adult patient aged from 18 yrs to 60 yrs posted for surgical excision of fibroadenoma and belongs to ASA-1 and ASA-2 those who have given consent.
排除标准
- •adult aged more than 60 years and anticipated difficult airway and those who have allergy to drugs pregnancy.
结局指标
主要结局
to determine the efficacy between ketamine-propofol and dexmedetomidine- ketamine on adequate sedation using Ramsay sedation scale
时间窗: Ketamine- Propofol is administered during the start of the surgery and using Ramsay sedation scale sedation score is given for every 5mins until the surgery is completed . | For another group patient receiving Ketamine-Dexmedetomidine sedation score is given after this drug administration using Ramsay sedation scale from the start of the surgery to every 5 mins until the surgery is completed
次要结局
- recovery time from sedation in cases posted for surgical excision of breast fibroadenoma(recovery time is assessed once the surgery is completed using modified Aldrete score is given every 5 mins upto 30 mins)
研究者
Dr Keerthana R
Gulbarga Institute of Medical Sciences