The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled，Double Blinded Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 4
- 主要终点
- Sedation assessment
研究概览
简要总结
Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia.
Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of awake tracheal intubation, however, the outstanding problem is serious respiratory depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced cough during general anesthesia induction.It is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dezocine prevents sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe and effective method for awake tracheal intubation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent；
- •Selective surgery and general anesthesia patients；
- •Age 18-65 yrs；
- •Anesthesia Society of American (ASA) Scale I~II；
排除标准
- •Mallampatis Ⅲ-Ⅳ；
- •Heat rate < 50 beats/minutes；
- •II-III Atrioventricular block；
- •Use of alpha agonist or antagonist within two weeks；
- •Use of opioid within 24 hours；
- •Serious heart, liver, kidney disease and cerebrovascular disease；
- •Allergic to the trial drug and other anesthesia drug contraindication；
- •Factors existed that affect language communication；
- •Any respiratory disease；
- •Unsuccessful intubation for 3 times or drop out during intubation.
研究组 & 干预措施
Dezocine
Dezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia
干预措施: Docozine (Drug)
Controlled
The same amount of saline is given for 10 seconds after surface anesthesia
干预措施: Saline (Drug)
结局指标
主要结局
Sedation assessment
时间窗: anesthesia induction
Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction
The variation of blood pressure
时间窗: anesthesia induction
The variation of blood pressure（mmHg) during anesthesia induction
The occurrence of cough response
时间窗: anesthesia induction
The cough scale is used to assess cough response the during anesthesia induction
The variation of heart rate
时间窗: anesthesia induction
The variation of heart rate(bpm）during anesthesia induction
The variation of pulse oxygen saturation
时间窗: anesthesia induction
The variation of pulse oxygen saturation(%) during anesthesia induction
次要结局
- The occurrence of cardiovascular events(from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery)
- The occurrence of treatment-related adverse events(from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery)
研究者
Xinqi Cheng
Clinical Professor of Anesthesia Department
The First Affiliated Hospital of Anhui Medical University