Effects of Adding Different Drugs for Preventing Cough Induced by Bronchoscopic Spraying of Local Anesthetics

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05072236
• Other study ID #: 202107071MIND
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Diseases
• Total Intravenous Anesthesia

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