Effect of Midazolam Premedication on Opioid-induced Mask Ventilation Difficulty During General Anesthesia Induction: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Difficulty of mask ventilation (Warters grading scale 0-10)
研究概览
简要总结
Mask ventilation has great importance during anesthesia induction because it is the only way to oxygenate patients who have lost consciousness and spontaneous breathing. Opioid-derived drugs used in anesthesia induction may cause difficulty in mask ventilation due to their chest wall rigidity and respiratory depressant effects. Adequate muscle relaxation and depth of anesthesia may assist with mask ventilation. It is known that premedication reduces anxiety and has a relaxing effect on airway muscles. Midazolam is frequently used in premedication because it has a rapid onset of action and does not cause hemodynamic changes. In addition, midazolam may relax the airway by acting directly on the airway smooth muscle and thus facilitate mask ventilation during anesthesia induction. In this study, the investigators will evaluate the effect of midazolam premedication on the mask ventilation after induction with remifentanil.
详细描述
American Society of Anesthesiologists (ASA) class I and II patients who are admitted to undergoing elective surgery under general anesthesia will be enrolled. Patients in midazolam group (Group M) will be treated with midazolam premedication (3 cc mixture of 0.035 mg/kg midazolam and normal saline; maximum midazolam dose, 3 mg) intravenously in a waiting area 3 minutes before transportation to an operating room, while 3 cc normal saline will be administered to control group (Group S) patients. The difficulty of mask ventilation will be evaluated before the injection of neuromuscular blocking during general anesthetic induction. The anxiety and sedation levels of patients will be estimated before the intervention and before anesthetic induction in an operating room. Remifentanil will be used as an opioid in the induction of the patients. In anesthesia induction, propofol 1.5 mg/kg will be given after remifentanil is infused at a dose of 0.30 µg/kg/min for three minutes. Before the patients were given muscle relaxants, the patients were evaluated with the Warter scale
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, Investigator, Outcomes Assessor)
盲法说明
The patients will be unaware of the group assignments and monitored in the reception area by a blinded anesthesiologist who will be in charge of the intervention and the evaluation of anxiety and sedation levels.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) class I and II patients
- •Patients who are scheduled for any elective surgery under general anesthesia
排除标准
- •age <18 or >60 years
- •current cervical spine disease or history of cervical spine surgery;
- •morbid obesity (body mass index, ≥35 kg/m2);
- •sleep apnea;
- •craniofacial anomaly;
- •allergic reaction to midazolam and remifentanil
- •chronic use of opioid, benzodiazepine, antipsychotic medications
- •pregnancy
- •presence of muscle weakness or dyspnea
研究组 & 干预措施
Group M
Patients of the Group M will be treated with midazolam premedication.
干预措施: Midazolam (Drug)
Group S
Group S patients are treated with 3 cc normal saline.
干预措施: Saline (Drug)
结局指标
主要结局
Difficulty of mask ventilation (Warters grading scale 0-10)
时间窗: During surgery at 30 seconds after loss of consciousness
The difficulty of mask ventilation will be assessed after 30 seconds from propofol induction (loss of consciousness) with Warter's scale. The Warters scale assigns points based on escalating levels of intervention necessary to ventilate the lungs such as the use of an airway device, increased inspiratory pressure, and two-person ventilation, which are all intended to overcome upper airway resistance to ventilation. Additionally, the Warters scale accounts for situations in which a poor quality mask seal inhibits mask ventilation. Thus, in the event that the target tidal volume of 5 ml/kg is not achieved, and the provider is unable to generate a peak inspiratory pressure of \>30 cmH20, additional points are assigned. The scale is scored between 0-10 and higher scores indicate worse mask application.
次要结局
- Anxiety level; Numerical Rating Scale(NRS) score (0 - 10)(One minute before the intervention in waiting area, and one minute before the anesthetic induction in operating room)
- Sedation level (Modified Observer's assessment of alertness/sedation (MOAA/S) scale)(One minute before the intervention in waiting area, and one minute before the anesthetic induction in operating room)