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临床试验/NCT05072236
NCT05072236已完成不适用

Effects of Adding Intravenous Lidocaine, Alfentanil Before Bronchoscopic Insertion for Preventing Cough During Bronchoscopic Spraying of Local Anesthetics in Non-intubated Bronchoscoopic Interventions

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
cough score

研究概览

简要总结

Cough is the most unwanted response during bronchoscopic interventions for hemodynamic instability, hypoxemia, and interruption of interventions. Topical lidocaine is recommended with a grade evidence in British Thoracic Society guideline. However, severe cough often induces during the initial bronchoscopic spraying of local anesthesia, follows with uneven spraying, spasm or arrythmias. In previous reports, there were many drugs and techniques investigated for preventing cough during broncoscopic spraying. As bronchoscopic interventions need more space and stability of airways to precisely operate on, few studies have focused on the effects of different drugs for preventing cough. In this study, Different intravenous drugs (lidocaine, alfentanil, compared to normal saline) is planned to be injected one minutes before bronchoscopic insertion, the responses to bronchoscopicly spraying local anestheticsuch as cough intensity, BIS levels, ANI, Transdermal O2 and CO2, respiration were recorded and analyzed.

详细描述

Cough is the most unwanted response during bronchoscopic interventions. Cough could lead to airway spasm, hemodynamic instability, desaturation, hypoventilation, and then interrupt the following interventions. In previous reports, lodicaine and other drugs given intravenously, inhalationally or trans-cricoidally have been investigated for preventing cough during conventional broncoscopic examinations. As bronchoscopic interventions were goaled to precise localization and operations with higher yield rate. Steady airways without endotracheal tubes are usually required. Topical lidocaine is recommended with a grade evidence in British Thoracic Society guideline. However, severe cough often induces during the initial bronchoscopic spraying of local anesthesia, follows with uneven spraying, spasm or arrythmias. There are few studies focused on the effects of different drugs for preventing cough even bronchoscopic spary of local anesthetics has become the routine pratice before interventions. In this study, different intravenous drugs (lidocaine, alfentanil, compared to normal saline) are planned to be injected one minutes before bronchoscopic insertion, the responses to bronchoscopic spraying local anesthetic were recorded and analyzed. Besdies cough scores, the following changes are recorded and compared: (1) status on visualization and the responses to spraying of vocal cords, (2) anesthetic depth (BIS levels), ANI scores (3) blood pressure and heart beats, (4) data of hemoglobin saturation (SPO2) and Transdermal O2 and CO2. We goaled to compare the effects of intravenous lidocaine and etomidate on cough intensity, hemodynamics, ventilation, and bronchoscopic withdrawl rate during bronchoscopic interventions with intravenous anethesia.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia.

排除标准

  • conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision

结局指标

主要结局

cough score

时间窗: from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees

cough severity x times Cough severity was graded on a 5-point scale: minimal cough, 1 point; moderate cough, 2 points; severe cough, 3 points; bouts of coughing, 4 points; and series of bouts of coughing, 5 points.

ANI scores from analgesia-nociception monitor (0-100)

时间窗: from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions

the changes of ANI scores (0-100)

BIS levels from EEG monitor

时间窗: from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions

the changes of BIS levels (0-100)

次要结局

  • MAP(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)
  • SPO2(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)
  • heart rate(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)
  • BTransdermal O2(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)
  • Transdermal CO2(from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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