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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

2026年11月7日 更新者:The First People's Hospital of Lianyungang

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

介入性

注册 (实际的)

190

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Jiangsu
      • Lianyungang、Jiangsu、中国
        • The Affiliated Lianyungang Hospital of Xuzhou Medical University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
  2. ASA grade I ~ III;
  3. Scheduled elective surgery under general anesthesia with tracheal intubation.

Exclusion Criteria:

  1. Patients with chronic cough (cough lasting >8 weeks) or asthma;
  2. Patients with a history of allergy to the drugs used during the study;
  3. Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月15日

初级完成 (实际的)

2026年6月16日

研究完成 (实际的)

2026年6月16日

研究注册日期

首次提交

2025年11月23日

首先提交符合 QC 标准的

2025年12月23日

首次发布 (实际的)

2026年1月7日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月7日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • KY-20250815003-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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