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

Not Applicable

Recruiting

• Conditions: Total Intravenous Anesthesia; Bronchoscopic Interventions; Lung Diseases
• Interventions: Procedure: bronchoscopic insertion

• Registration Number: NCT05072236
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-08
• Study Start: 2022-05-09
• Status Verified: 2024-03
• Primary Completion: 2024-06-30
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	bronchoscopic insertion	intravenous normal saline 5 mL 1 minute before bronchoscope insertion
lidocaine	bronchoscopic insertion	intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion
alfentanil	bronchoscopic insertion	intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion

Primary Outcome Measures

Name	Time	Method
cough score	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)	from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions	the changes of ANI scores (0-100)
BIS levels from EEG monitor	from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions	the changes of BIS levels (0-100)

Secondary Outcome Measures

Name	Time	Method
MAP	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying	mean arterial pressure, mmHg
SPO2	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying	SPO2, %
heart rate	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying	heart rate, beats/ minute
BTransdermal O2	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying	Transdermal O2, mmHg
Transdermal CO2	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying	Transdermal CO2, mmHg

Trial Locations

Locations (1)

National Taiwan University Cancer Center Hospital; 🇨🇳 Taipei, Taiwan