Comparative Study of Propofol- Ketamine vs Propofol- Fentanyl as Procedural Sedation for Total Intravenous Anaesthesia in Adults Undergoing Short Surgical Procedures
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Demographic Data (Age and Sex)
研究概览
简要总结
In this study, we are planning to evaluate the two TIVA regimes that are commonly used in practice- ketamine- propofol (ketofol) and fentanyl-propofol (fentofol). Studies have proven the efficacy of these two regimes in sedoanalgesia. In earlier studies, continuous infusions of either ketofol or fentofol have been prepared. However, in this study either ketamine or fentanylbis used only during induction, and maintainence in both cases is only with propofol. Keeping the factor of continuous infusion of propofol common in both the studies, hemodynamic parameters and recovery states are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant 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
- •All patients with normal airway (MPG 1&2).
- •Study subjects classified as American Society of Anesthesiologists (grade I or II).
- •All subjects scheduled for elective operations requiring general anesthesia and duration of surgery less than 40mins).
排除标准
- •Emergency Surgeries.
- •Patients allergic to eggs or soyproducts.
- •Patients with known or unanticipated difficult intubations.
- •Those with heart rhythms other than sinus.
- •Those with known allergy to study drugs.
结局指标
主要结局
1) Demographic Data (Age and Sex)
时间窗: Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
2) Intraoperative Monitoring of Hemodynamic Variability (Pulse Rate, SBP, DBP, Respiratory Rate, Spo2(%)
时间窗: Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
3) Intraoperative Sedation Level using BIS monitor
时间窗: Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
4) Post-Operative Ramsay Sedation Score
时间窗: Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
5) Time to Recovery (Modified Aldrete Score)
时间窗: Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
6) Post- operative Side Effects
时间窗: Initially, after 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 1 hr, 2hr, 4hr, 8hr, 12hr, 16hr, 20hr, 24hr
次要结局
- Overall patient satisfaction post-procedure(Immediate post-operatively, 4hrs, 8hrs, 1whrs, 16hrs, 20hrs, 24hrs)
研究者
Prashanthi Ballepu
Pandit Deendayal Upadhyay Medical College