Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Seganest
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Cough
研究概览
简要总结
Condition of the State: (terminated, recruiting, etc.) Terminated
Study Design: Main Objective:
Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia
详细描述
Phase of the study:
Phase IV
Intervention:
Drug: U Extubation
Other Names:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18-70 years
- •Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
- •Undergoing elective ear surgery
排除标准
- •Patients who are contraindicated remifentanil
- •Patients undergoing emergency surgery
- •Pulmonary Pathology (ASTHMA - COPD)
- •Index of body mass greater than 35
- •Background of respiratory failure three weeks prior to the procedure
研究组 & 干预措施
Extubation U
Remifentanil concentration between 2 - 3 ng/ml.
干预措施: Extubation U (Drug)
Extubation T
Remifentanil concentration between 3 - 4 ng/ml
干预措施: Extubation T (Drug)
结局指标
主要结局
Cough
时间窗: It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated
Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated. Cough Scale * Grade 0 = No cough * Grade 1 = Mild (only episode of cough) * Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds) * Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities).
次要结局
- Wake time.(During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.)
- Ramsay scale at the time of extubation(During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered)
研究者
LUIS ALBERTO TAFUR B
Principal Investigator
Seganest