The Effectiveness of comparision of Ketamine and Dexmedetomidine (KETODEX) infusion versus Ketamine and Propofol(KETOFOL) infusion for sedation during flexible bronchoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of Ketamine and Dexmedetomidine (Ketodex) vs. Ketamine and Propofol (Ketofol) for sedation during flexible bronchoscopy.
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of two sedative drug combinations—KETODEX and KETOFOL—for sedation in patients undergoing flexible bronchoscopy. Both regimens are used in clinical practice; however, comparative evidence is limited. The primary outcome will be achieving adequate sedation defined by a Ramsay Sedation Score (RSS) >4. Secondary outcomes include patient and bronchoscopist satisfaction, incidence of complications, and requirement for rescue drugs. This randomized, double-blind study will be conducted at a single center in Gujarat, India.
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 85.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 ,2,3 Spontaneously breathing patients scheduled for flexible bronchoscopy under sedation.
排除标准
- •Allergy to ketamine, propofol, or dexmedetomidine Tracheostomized or intubated patients Patients with heart block or recent myocardial infarction Patients who convert to mechanical ventilation.
结局指标
主要结局
To compare the effectiveness of Ketamine and Dexmedetomidine (Ketodex) vs. Ketamine and Propofol (Ketofol) for sedation during flexible bronchoscopy.
时间窗: post procedure for 1 hour
次要结局
- To assess patient satisfaction, bronchoscopy satisfaction, coughing response of patient, assess the need for other drugs, assess the intraprocedure and post procedure complications(Post procedure 1 hour)
研究者
Dr Birva Khara
Pramukhswami Medical college, Bhaikaka University