替格列定与舒芬太尼作为全麻诱导前用药的咳嗽反应比较
徐州医科大学附属连云港医院
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration <1 second; Grade IV, continuous coughing with a duration >15 seconds.
研究概览
详细说明
Using a computer-generated randomized number table, patients were divided into two groups: the experimental group receiving Tiliglitidine (T group) at 20-50ug/kg, and the control group receiving Sufentanil (S group) at 0.2-0.4 μg/kg. After patients arrived in the operating room, routine monitoring including non-invasive blood pressure, electrocardiogram, and oxygen saturation was performed, and intravenous access was established. Patients were oxygenated and given the study drug before anesthesia induction. No other drugs were administered to the patients before giving the study drug. During anesthesia induction, patients received intravenous injection of Tiliglitide or Sufentanil according to their group. The severity of coughing was graded based on the number of coughing episodes: graded by the number and duration of coughs: Grade I, no cough, breathing regular; Grade II, a single mild cough; Grade III, multiple coughs, lasting less than 15 seconds; Grade IV, continuous coughs, lasting more than 15 seconds.
This study was single-blind,the attending anesthesiologist could not be blinded to group allocation. However, the investigator who assessed cough, the patients, the intraoperative data recording nurse, the data collectors, and the statistician were all blinded.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Jiangsu
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Lianyungang、Jiangsu、中国
- The Affiliated Lianyungang Hospital of Xuzhou Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- ASA grade I ~ III;
- Scheduled elective surgery under general anesthesia with tracheal intubation.
Exclusion Criteria:
- Patients with chronic cough (cough lasting >8 weeks) or asthma;
- Patients with a history of allergy to the drugs used during the study;
- Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Tegilerdine group
Administer 20-50µ/kg of Tegilerdine before induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction. |
Inject Tegilerdine in the induction of general anesthesia |
|
有源比较器:Sufentanil group
Administer sufentanil 0.2-0.4 µg/kg before the induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction. |
Inject Sufentanil in the induction of general anesthesia |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of choking cough response
大体时间:2 minutes after administration
|
Two minutes after administration of the study drugs (Tegilerdine/Sufentanil), any clear coughing action is considered an 'occurrence'. |
2 minutes after administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Grading of choking and coughing response
大体时间:2 minutes after administration
|
Grading based on the number and duration of coughs: Grade I, no coughing, breathing is even; Grade II, a single mild cough; Grade III, multiple coughs lasting less than 15 seconds; Grade IV, continuous coughing lasting more than 15 seconds |
2 minutes after administration
|
|
Blood pressure
大体时间:before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4)
|
Blood pressure before and after administration, and before and after intubation |
before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4)
|
|
Heart rate
大体时间:before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4)
|
heart rate before and after administration, and before and after intubation |
before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4)
|
|
Adverse reaction
大体时间:2 minutes after administration
|
such as respiratory depression, vomiting, nausea, itching, etc.) |
2 minutes after administration
|
合作者和调查者
调查人员
- 研究主任:Xiaobao Zhang, Doctor、Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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