Effect of intravenous lidocaine and dexmedetomidine on response to tracheal suctioning in intensive care unit patients - A prospective, randomised, double blinded, cross over study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numerical rating scale score
研究概览
简要总结
Inour study, we evaluated the effects of two different pharmacologicalinterventions (dexmedetomidine or lidocaine) on tracheal suctioning response.
Randomisationwas done as per a computer generated randomisation table. The blinding wasensured in the following way:
Syringe Acontained either dexmedetomidine or saline (10 mL) which was administered over5 minutes as an infusion starting from time 0 till 5th minute.
Syringe Bcontained either lidocaine or saline (5 mL) which was administered as a bolusinjection at 4th minute.
At the end of 4thminute, patients received 100% oxygen for further 60 seconds. At the end ofthis, tracheal suctioning was carried out over 15 seconds with all asepticprecautions. The tracheal suction catheter size was determined by the followingformula [Suction catheter size in French = (internal diameter of endotrachealtube in mm × 3) ÷ 2] and this was kept constant throughout the study for agiven patient.
RichmondAgitation Sedation Scale (RASS) was noted at the beginning of the study.Response to tracheal suctioning was assessed both objectively and subjectively.Observer 3 rated the pain / discomfort on a scale of 0-10 (numerical ratingscale) both prior to and after suctioning. Variables such as heart rate (HR),systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterialpressure (MAP) or any change in the rhythm pattern including ectopics etc were noted. These variables werenoted at every minute starting just prior to suctioning and till 5 minutesafter suctioning and then they were noted at 10th and 15thminute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator 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
- •All patients that have a tracheal tube in situ in ICU.
排除标准
- •1.Patients with known or suspected allergy to any of the study drugs (dexmedetomidine, lidocaine) 2.Patients with seizure disorder 3.Patients receiving neuromuscular blockade / with known neuromuscular disease 4.Patients who were hypotensive requiring more than one inotrope / vasopressor 5.Patients that were delirious or had disease condition that would confuse the behaviour assessment, such as decerebrate posturing.
结局指标
主要结局
Numerical rating scale score
时间窗: Baseline, at one minute interval for five minutes starting from the point of tracheal suctioning and at 10th and 15th minute following tracheal suctioning. | Behavioural response and numerical rating was assessed just prior to tracheal suctioning and in the following minute after tracheal suctioning
Behavioural response score
时间窗: Baseline, at one minute interval for five minutes starting from the point of tracheal suctioning and at 10th and 15th minute following tracheal suctioning. | Behavioural response and numerical rating was assessed just prior to tracheal suctioning and in the following minute after tracheal suctioning
Haemodynamic fluctuations of 20% from baseline
时间窗: Baseline, at one minute interval for five minutes starting from the point of tracheal suctioning and at 10th and 15th minute following tracheal suctioning. | Behavioural response and numerical rating was assessed just prior to tracheal suctioning and in the following minute after tracheal suctioning
次要结局
- Complications(Arrhythmias, desaturation)