Application of Visual Laryngeal Mask Airway Combined With Endotracheal Intubation in Non-head and Neck Surgery Under General Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Intubation time (second)
研究概览
简要总结
To study the advantages of visual laryngeal mask combined with endotracheal intubation in general anesthesia surgery, we compared intubation time, intubation times and intubation success rate of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions, at the same time, the laryngeal mask displacement rate, volume of secretion in airway, the incidence of laryngeal spasm, the incidence and severity of postoperative oropharyngeal pain were also compared between two groups.
详细描述
After entering the operating room, the patient received routine general anaesthesia monitoring, and anesthesia induction was conducted after three-party verification. Propofol (plasma target-controlled concentration: 3.5ug/ mL), midazolam (0.05mg/kg), fentanyl (2ug/kg) and rocuronium (0.6mg/kg) were used to induce the drugs.
After anesthesia induction, visual laryngeal mask airway was placed in the visual group and endotracheal intubation was guided under visual conditions. In the non-visual group, after judging the position of laryngeal mask by clinical experience, endotracheal intubation was inserted blindly. Selection of laryngeal mask airway (LMA) model based on: the ideal body weight of the patient, 3 was selected for the body weight of 30-50kg, 4 for the body weight of 50-70kg and 5 for the body weight > 70kg. The endotracheal tube intubation time, intubation times and intubation success rate of the two groups were recorded.
During the operation, propofol and fentanyl are used for anesthesia maintenance, and the anesthesiologist adjusts the anesthesia depth according to his/her own experience. Ten minutes before the end of the operation, endotracheal intubation was removed and the laryngeal mask airway was retained. The displacement rate of the laryngeal mask airway, the volume of secretion in airway and the incidence of laryngeal spasm were compared between the two groups.
After the surgery, the residual muscle relaxation was antagonized, and the laryngeal mask was removed after the patient regained consciousness and reached the extubation criteria. The hemodynamic parameters and the severity of cough during laryngeal mask airway removal were recorded. The incidence and severity of oropharyngeal pain, oropharyngeal numbness, hoarseness, nausea, and vomiting were assessed immediately after the patient woke up and was followed up before leaving the recovery room and on the first day after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patients, surgeons and the ones who collect data will be masked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70
- •American Society of Anesthesiologist physical status (ASA) Ⅰ-II
- •Undergoing non-head and neck surgery under general anesthesia with endotracheal intubation
- •Sign the informed consent voluntarily;
排除标准
- •Not willing to participate in the study or not able to sign the informed consent
- •American Society of Anesthesiologist physical status (ASA) Ⅲ-Ⅳ
- •Weight <30kg or BMI>40 kg/m2
- •High risk of reflux aspiration
- •Combined with severe respiratory disease
- •Combined oropharyngeal lesions affect the laryngeal mask insertion
- •Oropharyngeal pain in the last two weeks.
结局指标
主要结局
Intubation time (second)
时间窗: intraoperative
Compare the time of endotracheal intubation through laryngeal mask airway under visual and non-visual conditions
次要结局
- Success rate of the endotracheal intubation (%)(intraoperative)
- Incidence of oropharyngeal pain as assessed by the VAS(postoperative one day)
- Displacement rate of the laryngeal mask airway (%)(Immediately after operation)
- Incidence and severity of hoarseness as assessed by a numerical scale(postoperative one day)
研究者
Xia Ruan
Attending doctor of the Department of Anesthesiology
Peking Union Medical College Hospital