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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05072236
Other study ID # 202107071MIND
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 9, 2022
Est. completion date July 30, 2024

Study information

Verified date March 2024
Source National Taiwan University Hospital
Contact cheng yajung
Phone 0930050762
Email chengyj@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date July 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia. Exclusion Criteria: - conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
bronchoscopic insertion
After intravenous anesthesia is stabilized with BIS levels between 50-70, Intravenous lidocaine 1.5 mg/kg, or alfentanil 10 ug/kg, or 5 mL normal saline will be injected. Bronchoscopic insertion will be started 1 minute later. After seeing the vocal cords, local spraying of 2% will be initiated from vocal cords, trachea, and bilateral bronchial trees.

Locations

Country Name City State
Taiwan National Taiwan University Cancer Center Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary cough score 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. from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees
Primary BIS levels from EEG monitor the changes of BIS levels (0-100) from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
Primary ANI scores from analgesia-nociception monitor (0-100) the changes of ANI scores (0-100) from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
Secondary MAP mean arterial pressure, mmHg from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Secondary heart rate heart rate, beats/ minute from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Secondary SPO2 SPO2, % from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Secondary Transdermal CO2 Transdermal CO2, mmHg from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Secondary BTransdermal O2 Transdermal O2, mmHg from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
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