Comparative study of Propofol -Ketamine Vs Propofol -Fentanyl combination for hemodynamic stability and analgesia in adult patients undergoing elective short surgical procedures
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare hemodynamic stability of Propofol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures
研究概览
简要总结
Introduction - Total Intravenous Anaesthesia (TIVA) has many advantages like minimal cardiac depression, decreased oxygen consumption, avoidance of post operative diffusion hypoxia and less incidence of post operative nausea and vomiting etc. Various studies are being done to find out an ideal agent for TIVA and in our study we are evaluating two drug combinations to find out the same.
Aims and Objectives- We aim to evaluate two drug combinations, Propofol -Fentanyl and Propofol -Ketamine for their induction, maintenance and recovery characteristics and to compare their hemodynamic stability and post operative analgesic effect.
Material and Methods- The study will be conducted in a comparative manner in GGS Medical College and Hospital, Faridkot on 60 patients belonging to American Society of Anesthesiologists (ASA) Grade I and II; aged between 18-60 years who are scheduled for elective short surgical procedures under total intravenous anaesthesia.
Patients will be allocated into two groups of 30 each.
Group F will receive 1.5mg/kg of Propofol and 2 mcg/kg of fentanyl for induction and 2mg/kg/hr of propofol and 2 mcg/kg/hr of fentanyl for maintenance of anaesthesia intravenously.
Group K will receive 1.5mg/kg of propofol and 1mg/kg of ketamine for induction of anaesthesia and 2mg/kg/hr of ketamine for maintenance of anaesthesia intravenously.
The patients will be observed for their intra operative and post operative hemodynamic changed followed by their post operative rescue analgesic requirement and any adverse effects for 24 hrs. The data will be then statically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients from 18-60years of age scheduled for elective surgeries of 30-90 mins duration and belonging to ASA Grade I and II.
排除标准
- •Patients who are hemodynamically unstable History of anaphylaxis or allergy to the study drugs Pregnant females History of head injury or seizure disorders Psychiatric illness or drug abuse BMI more than equal to 30 kg per metre square.
结局指标
主要结局
To compare hemodynamic stability of Propofol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures
时间窗: To compare hemodynamic stability of Propofol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures of 30-90 minutes duration over a period of 1.5 years
次要结局
- To compare analgesia in patients recieving Profol-Fentanyl Vs Propofol -Ketamine combination in elective short surgical procedures of duration 30 to 60 minutes(Outcome will be assessed at the end of one & half year of study)
研究者
Shaishabi Bhowmick
Guru Gobind Singh Medical College and Hospital, Faridkot