Effectiveness of nebulized dexmedetomidine for premedication in flexible bronchoscopy in Indian patients- a prospective, randomized, double blinded study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Composite score during the bronchoscopy procedure.
研究概览
简要总结
A written informed consent will be taken from all study participants. For patients who meet the inclusion criteria, demographic details like age, gender, height, weight, BMI, prior bronchoscopy procedure, current indication for bronchoscopy and the procedures done during bronchoscopy will be recorded in the study proforma.
Patients undergoing FB will be randomized in a one is to one ratio as per a computer generated randomization table and will be allocated to any of the two groups (Group A or Group B).
Patients in group A will receive nebulized dexmedetomidine at 1 mcg/Kg, diluted with 0.9% saline into 5 ml. Patients in group B receive 5 ml of 0.9% saline nebulization prior to bronchoscopy. A composite scoring will be done by observer C at the level of nasopharynx, during passage through trachea and when crossing the carina. Heart rate, cardiac rhythm. Non-invasive blood pressure (NIBP), respiratory rate, and pulse oximetry saturation will be recorded before the start of bronchoscopy, monitored continuously during the procedure till its completion and 10 minutes post procedure. Patient is further assessed after 24 hours and asked to give their opinion on the procedure, the quality of sedation, discomfort, any adjustment needed in the dose of sedation and willingness for a repeat procedure if required
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
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
- •a.Patients with known or suspected allergy to lignocaine or Dexmedetomidine b.Patients with renal or hepatic insufficiency c.Patients with seizure disorder d.COPD patients with FEV1 <50% e.Patients with psychiatric disorder f.Hemodynamically unstable patients including cardiac failure g.Heart rate <50 beats per min or second or third degree heart block h.Patients with body weight more than 70kg.
- •i.Pregnancy and lactation j.Patients posted for bronchoscopy and not consenting for study.
- •Patients with nasal abnormalitues/infectionn.
结局指标
主要结局
1.Composite score during the bronchoscopy procedure.
时间窗: Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy. | Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure. | Patient is assessed 2 hours post procedure for other variables. | Theres no follow up required for the study.
2.Numerical Rating Scale (NRS) for pain intensity and distress.
时间窗: Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy. | Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure. | Patient is assessed 2 hours post procedure for other variables. | Theres no follow up required for the study.
3.Visual Analogue Scale (VAS) for cough.
时间窗: Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy. | Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure. | Patient is assessed 2 hours post procedure for other variables. | Theres no follow up required for the study.
4.Ramsay sedation score (RSS).
时间窗: Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy. | Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure. | Patient is assessed 2 hours post procedure for other variables. | Theres no follow up required for the study.
5.Ease of bronchoscopy procedure as assessed by Observer B
时间窗: Primary outcomes will be assessed during bronchoscopy and at the end of bronchoscopy. | Secondary parameters like vital parameters will be assessed at baseline, at the start of the procedure, 5 minutes into the procedure, 10 minutes, at the end of scopy and 10 minutes post procedure. | Patient is assessed 2 hours post procedure for other variables. | Theres no follow up required for the study.
次要结局
- 1.Willingness for repeatability of the procedure as felt by patient.(2.Variations in heart rate (HR), blood pressure (BP), oxygen saturation (SpO2).)