Clinical trial NCT05072236: 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
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Total Intravenous Anesthesia
Bronchoscopic Interventions
Keywords: cough
desaturation
ventilation
bronchoscopic interventions
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: cough score
timeFrame: from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees
measure: BIS levels from EEG monitor
timeFrame: from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
measure: ANI scores from analgesia-nociception monitor (0-100)
timeFrame: from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
Secondary outcomes:
measure: MAP
timeFrame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
measure: heart rate
timeFrame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
measure: SPO2
timeFrame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
measure: Transdermal CO2
timeFrame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
measure: BTransdermal O2
timeFrame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center Hospital
Study officials:
affiliation: National Taiwan University Hospital cancer center
name: Yajung Cheng
role: STUDY_CHAIR
References: