Intravenous Lidocaine Continuous-infusion to Supress of Cough Reflex During Anesthesia Emergence: Dose-finding Adaptive Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Cough during anesthesia emergence
研究概览
简要总结
Introduction: Although inflating tracheal cuff using lidocaine is effective for cough suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during anesthesia emergence is not determined yet. Objective: the objectives of this study are to determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during extubation by sex and age group.
详细描述
Ideal patient weight in kg will be considered.
Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on the incidence of emergence cough in the previous patient of the same group:
- It will increase if coughed in a probability of 95%
- It will decrease if not coughed in a probability of 5%.
- It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will receive remifentanil 0.025mcg/kg.min continuous infusion until extubation.
Patients groups will be determined by sex and age group (18-60 or >60 years old), therefore, four independent groups will be studied:
- Female 18 to 60 years old
- Male 18 to 60 years old
- Female > 60 years old
- Male > 60 years old
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)
盲法说明
A study participant who will not participate during assessment of the main outcome will prepare the drug solutions to be infused at 10ml/h accordingly to the response of the previous patient and to the dose calculated for the next patient. The participant who will verify the main outcome during anesthesia emergence will not know the dose the patient is receiving. Participants will not be informed of the dose they will receive. The outcomes assessor will not handle individual data and statistical analysis plan was developed in advance.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands study risks and benefits, signs informed consent.
- •Not pregnant.
- •Not an airway surgery
- •No acute or chronic respiratory disease.
- •Non smoker
- •No chronic cough
排除标准
- •Any protocol violation.
研究组 & 干预措施
Female 18 to 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
干预措施: Lidocaine (Drug)
Male 18 to 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
干预措施: Lidocaine (Drug)
Male > 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
干预措施: Lidocaine (Drug)
Female > 60 years old
This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Cough during anesthesia emergence
时间窗: Anytime during anesthesia emergence, before extubation.
Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation.
次要结局
未报告次要终点
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of Anesthesiology
Brasilia University Hospital