Comparison between intravenous Midazolam(0.035mg/Kg)-Fentanyl(25mcg)combination and intravenous Dexmedetomidine(0.75mcg/kg) in flexible bronchoscopy-A prospective, randomized, double blinded study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To study the effects of intravenous Midazolam(0.035mg/kg)-Fentanyl(25mcg) combination and intravenous Dexmedetomidine (0.75mcg/kg) on patient response to flexible bronchoscopy.
研究概览
简要总结
Patient comfort during an invasive procedure like flexible bronchoscopy is of great importance. use of appropriate sedative in correct dosage will provide ease of bronchoscopy. there are only limited studies comparing the effects of of midazolam-fentanyl combination and dexmedetomidine in flexible bronchoscopy. ultimate goal of this study is to find a suitable drug at a dose that does not produce any serious adverse effects so that pulmonologists can safely perform bronchoscopy with ease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients in the age group 18 to 65 years undergoing flexible bronchoscopy in the Department of Respiratory Medicine.
排除标准
- •1.Patients with known or suspected allergy to Midazolam or Dexmedetomidine.
- •2.Patients with renal impairment 3.Patients with hepatic impairment 4.Patients with seizure disorder.
- •5.COPD patients with Forced Expiratory Volume (FEV1 )< 50%.
- •6.Patients with psychiatric illness.
- •7.Haemodynamic instability including cardiac failure.
- •8.Second or third degree heart block/ Heart rate <50/min 9.Patients weighing more than 70kg.
- •10.Pregnancy and lactation.
- •11.Hypovolemia.
- •12.Oxygen Saturation < 90%.
结局指标
主要结局
To study the effects of intravenous Midazolam(0.035mg/kg)-Fentanyl(25mcg) combination and intravenous Dexmedetomidine (0.75mcg/kg) on patient response to flexible bronchoscopy.
时间窗: before the administration of study drugs, at the start of flexible bronchoscopy, 5 minutes after the start of bronchoscopy, 10 minutes after the start of bronchoscopy and 10 minutes after the completion of bronchoscopy
次要结局
- 1. Duration of bronchoscopy procedure.(2. Number of doses of rescue medication given.)