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

Primary Purpose

Lung Diseases, Total Intravenous Anesthesia, Bronchoscopic Interventions

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
bronchoscopic insertion
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Diseases focused on measuring cough, desaturation, ventilation, bronchoscopic interventions

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Cancer Center HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

normal saline

lidocaine

alfentanil

Arm Description

intravenous normal saline 5 mL 1 minute before bronchoscope insertion

intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion

intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion

Outcomes

Primary Outcome Measures

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.
BIS levels from EEG monitor
the changes of BIS levels (0-100)
ANI scores from analgesia-nociception monitor (0-100)
the changes of ANI scores (0-100)

Secondary Outcome Measures

MAP
mean arterial pressure, mmHg
heart rate
heart rate, beats/ minute
SPO2
SPO2, %
Transdermal CO2
Transdermal CO2, mmHg
BTransdermal O2
Transdermal O2, mmHg

Full Information

First Posted
September 14, 2021
Last Updated
November 16, 2022
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05072236
Brief Title
Effects of Adding Different Drugs for Preventing Cough Induced by Bronchoscopic Spraying of Local Anesthetics
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Total Intravenous Anesthesia, Bronchoscopic Interventions
Keywords
cough, desaturation, ventilation, bronchoscopic interventions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
intravenous normal saline 5 mL 1 minute before bronchoscope insertion
Arm Title
lidocaine
Arm Type
Active Comparator
Arm Description
intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion
Arm Title
alfentanil
Arm Type
Experimental
Arm Description
intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion
Intervention Type
Procedure
Intervention Name(s)
bronchoscopic insertion
Other Intervention Name(s)
bronchoscopic spraying of 2% lidocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
cough score
Description
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.
Time Frame
from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees
Title
BIS levels from EEG monitor
Description
the changes of BIS levels (0-100)
Time Frame
from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
Title
ANI scores from analgesia-nociception monitor (0-100)
Description
the changes of ANI scores (0-100)
Time Frame
from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
Secondary Outcome Measure Information:
Title
MAP
Description
mean arterial pressure, mmHg
Time Frame
from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Title
heart rate
Description
heart rate, beats/ minute
Time Frame
from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Title
SPO2
Description
SPO2, %
Time Frame
from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Title
Transdermal CO2
Description
Transdermal CO2, mmHg
Time Frame
from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Title
BTransdermal O2
Description
Transdermal O2, mmHg
Time Frame
from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
cheng yajung
Phone
0930050762
Email
chengyj@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yajung Cheng
Organizational Affiliation
National Taiwan University Hospital cancer center
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Cancer Center Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yajung Cheng

12. IPD Sharing Statement

Plan to Share IPD
No

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

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