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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Lung Diseases, Total Intravenous Anesthesia, Bronchoscopic Interventions

Intervention / Treatment
-----------------
* Procedure: bronchoscopic insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal saline<br>intravenous normal saline 5 mL 1 minute before bronchoscope insertion | Procedure: bronchoscopic insertion<br>* 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.<br>* Other names: bronchoscopic spraying of 2% lidocaine;|
| Active Comparator: lidocaine<br>intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion | Procedure: bronchoscopic insertion<br>* 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.<br>* Other names: bronchoscopic spraying of 2% lidocaine;|
| Experimental: alfentanil<br>intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion | Procedure: bronchoscopic insertion<br>* 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.<br>* Other names: bronchoscopic spraying of 2% lidocaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| BIS levels from EEG monitor | the changes of BIS levels (0-100) | from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAP | mean arterial pressure, mmHg | from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying | 
| heart rate | heart rate, beats/ minute | from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying | 
| SPO2 | SPO2, % | from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying | 
| Transdermal CO2 | Transdermal CO2, mmHg | from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying | 
| BTransdermal O2 | Transdermal O2, mmHg | from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cough, desaturation, ventilation, bronchoscopic interventions