Efficacy of Ketamine-Propofol versus Propofol on BIS defined induction of anaesthesia in ENT Surgeries- A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To assess the time required in minutes to attain the target BIS value of less than or equal to 60 in both the groups
研究概览
简要总结
This study is designed to compare the use of Ketamine-Propofol against Propofol alone in relation to Bispectral Index (BIS) values for the induction of anaesthesia in ENT surgeries. The primary goal of the research is to assess the time taken to reach a BIS value of 60 or lower in both study groups. Secondary objectives include evaluating the duration from induction to the loss of verbal response in both groups, determining how often additional propofol doses are needed when BIS values do not fall to 60 or below within a specified timeframe, and analyzing intraoperative and postoperative hemodynamic parameters.
We hypothesize that patients receiving Ketamine-Propofol will experience a shorter induction time and a reduced incidence of hypotension while still achieving sufficient anaesthesia induction.
The findings of this study will guide the selection of a more effective drug combination for a smoother, faster, and hemodynamically stable induction of anaesthesia in ENT surgeries. Additionally, this research aims to clarify the role of BIS monitoring in ENT surgeries, allowing for timely and appropriate drug dosing to maintain an adequate depth of anaesthesia. This will help anaesthesiologists avoid underdosing or overdosing, leading to smoother emergence and fewer complications.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society of Anaesthesiologists (ASA) Physical Status I and II posted for elective ENT surgeries.
- •2.Patients of age 18-60 years of either sex.
- •3.Surgeries with a duration less than or equal to 120 minutes.
- •4.Patients with normal BMI (18-25 kg/m2).
排除标准
- •1.Patient refusal.
- •2.History of allergy to the drugs used in the study like Ketamine, Propofol, Fentanyl, Paracetamol.
- •3.Patients with a history of difficult airway.
结局指标
主要结局
To assess the time required in minutes to attain the target BIS value of less than or equal to 60 in both the groups
时间窗: BIS value will be monitored at 0 to 10 minutes at 1 minute interval follwed by at 20 minutes and 30 minutes.
次要结局
- Time in minutes required from induction to loss of verbal response in both groups of patients.
- Total additional dose of Propofol required in both the groups if BIS more than or equal to 60.(0 to 10 minutes)
- Measure the haemodynamic parameters, SBP, DBP, MAP- (in mm Hg), Heart rate- (in Beats/ minute).(0 to 10 minutes, 20 minutes & 30 minutes intraoperatively. 0 minute, 30 minutes & 60 minutes post operatively.)
研究者
Dr Medhavrat Nirala
Kalinga Institute of Medical Sciences, Bhubaneswar