Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Sore throat intensity 2
研究概览
简要总结
Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).
详细描述
Eligible patients undergoing general anesthesia will be randomized and assigned to three groups:
Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%
The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •American Society of Anesthesiologists classification (ASA) category 1 or 2
- •High pressure, low volume endotracheal tube - (Lo-pro)
排除标准
- •Ear nose and throat and cranial surgery
- •Ear nose and throat pathologies
- •Asthma and bronchial hyperreactivity
- •Chronic cough
- •Cognitive disorders
- •Swallowing disorders
- •Corticotherapy during the last week
- •Allergy to lidocaine
- •Urgent surgery
- •Nasogastric, oro-gastric
- •Ventral position
- •More than 2 intubation attempts
- •Continuous intravenous infusion of lidocaine intraoperatively.
研究组 & 干预措施
Air
Endotracheal tube cuff inflation with air
干预措施: cuff inflation with air (Other)
Air
Endotracheal tube cuff inflation with air
干预措施: Induction of anesthesia (Other)
Air
Endotracheal tube cuff inflation with air
干预措施: Maintenance of anesthesia (Other)
Air
Endotracheal tube cuff inflation with air
干预措施: Endotracheal intubation (Other)
Air
Endotracheal tube cuff inflation with air
干预措施: Systematic post-operative analgesia (Other)
Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 1%
干预措施: cuff inflation with lidocaine 1% (Drug)
Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 1%
干预措施: Induction of anesthesia (Other)
Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 1%
干预措施: Maintenance of anesthesia (Other)
Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 1%
干预措施: Endotracheal intubation (Other)
Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 1%
干预措施: Systematic post-operative analgesia (Other)
Lidocaine 2%
Endotracheal tube cuff inflation with Lidocaine 2%
干预措施: cuff inflation with lidocaine 2% (Drug)
Lidocaine 2%
Endotracheal tube cuff inflation with Lidocaine 2%
干预措施: Induction of anesthesia (Other)
Lidocaine 2%
Endotracheal tube cuff inflation with Lidocaine 2%
干预措施: Maintenance of anesthesia (Other)
Lidocaine 2%
Endotracheal tube cuff inflation with Lidocaine 2%
干预措施: Endotracheal intubation (Other)
Lidocaine 2%
Endotracheal tube cuff inflation with Lidocaine 2%
干预措施: Systematic post-operative analgesia (Other)
结局指标
主要结局
Sore throat intensity 2
时间窗: at 2 hours after extubation
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Cough intensity 2
时间窗: at 2 hours after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 6
时间窗: at 6 hours after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 24
时间窗: at 24 hours after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 0
时间窗: hour 0 after extubation
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Sore throat intensity 0
时间窗: hour 0 after extubation
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 24
时间窗: at 24 hours after extubation
Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 6
时间窗: at 6 hours after extubation
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
次要结局
未报告次要终点
研究者
Ogarite Habib
Principal Investigator
Saint-Joseph University