Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Decrease of the incidence of sore-throat.
研究概览
简要总结
The aim of the study is to test the effectiveness of a solutions of beclomethasone repeatedly instilled through the supraglottic line of the endotracheal tube on post-extubation airway disturbances related to tracheal intubation. The primary endpoint will be the decrease of the incidence of sore-throat 15 minutes and 12 hours after extubation. Secondary endpoints will regard the effects on hoarseness and cough.
详细描述
The study will be prospective, randomized, controlled. Patients will be premedicated with diazepam, 0.1 mg/Kg and scopolamine, 0.05 mg/Kg, i.m. one hour prior to their arrival in the operatory theatre. Anesthesia will be induced by fentanyl, 0.1 mg, and propofol, 1.5-2 mg/Kg. After obtaining muscle relaxation with cis-atracurium, 0.15 mg/Kg, a Taper Guard Evac Murphy Eye Oral Tracheal Tube (Mallinkrodt, Mirandola, Italy) with an internal diameter of 9 in men and 8 in women, will be positioned. These tubes have a line for suctioning above the cuff. The cuff pressure will be set to 20-30 cmH2O and checked every 6 hours with a proper inflating device. Patients will be connected to a mechanical ventilator and anesthesia will be maintained with sevoflurane 1-2.5% and remifentanil, 0.05-0.15 mcg/Kg/min. At the end of surgery, patients will be moved to the cardiac surgical intensive care, connected to a mechanical ventilator, and sedated with propofol and remifentanil until the conditions needed for weaning from the ventilator (control of bleeding, cardiovascular stability, thermal equilibrium) are achieved. Then, propofol infusion will be stopped and remifentanil dosage decreased to 0.02-0.05 mcg/Kg/min. After a successful t-tube trial of spontaneous breathing, tracheal tubes will be removed. Remifentanil infusion will be continued and dosage titrated on patient pain evaluated with a VAS scale; paracetamol 1 g will be given if need be.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intensive care postoperative admission
- •tracheal intubation for a total lapse of time between 10 and 18 hours
排除标准
- •age < 18,
- •hypersensitivity to FANS and/or corticosteroids,
- •a medical history positive for diseases affecting upper airways or trachea or causing cough, hoarseness, or voice disorders;
- •intubation after more than two attempts or with aids (i.e. stylets, Airtraq, Glidescope, Fibroscopy).
研究组 & 干预措施
Beclomethasone
Patients will receive beclomethasone, 0.8 mg of saline to a volume of 8 mL, three times through the line for suctioning above the cuff: a) after positioning the tube; b) at the arrival in the cardiac intensive care unit; c) just prior to start respiratory weaning. The solution will be aspirated 15 minutes after the instillation.
干预措施: Beclomethasone (Drug)
Placebo
Patients will receive 8 mL of saline without any drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Decrease of the incidence of sore-throat.
时间窗: Fifteen minutes after removing the tracheal tube
Presence and intensity of sore throat by asking the patients to quantify it on a 0-3 scale Sore Throat Scoring System\* 0 No sore throat 1. Minimal sore throat, less severe than with a cold 2. Moderate sore throat, similar to that noted with a cold 3. Severe sore throat, more severe than noted with a cold
次要结局
- Decrease of the incidence of hoarseness(Fifteen minutes after removing the tracheal tube)
研究者
Temistocle Taccheri
MD, resident of Department of Anesthesia and Intensive Care , Policlinico A. Gemelli , Catholic University of the Sacred Heart in Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS