Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376942
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
Post Graduate Institute of Medical Education and Research Chandigarh
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAFCOF
Brief Summary:
No study has examined the role of inhaled glycopyrrolate on mucus secretion We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion thereby decreasing cough and thus improving patient comfort during bronchoscopy In this study we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy
Detailed Description:
Bronchoscopy is a minimally invasive endoscopic technique for direct visualization of airways with diagnostic and therapeutic intent In 1897 Killian laid the foundation of bronchoscopy by extracting an animal bone from the right main bronchus of a farmer using rigid esophagoscope In 1966 Shigeto Ikeda developed a prototype of flexible bronchoscope Since its inception flexible bronchoscope has undergone advancements in design and technology The technological advancements in the recent decades have improved diagnostic yield and safety with low morbidity and mortality Unfortunately the occurrence of cough during flexible bronchoscopy makes the procedure difficult and increases procedure time with patient discomfort
Owing to the lack of clinical benefits and possible hemodynamic changes the British Thoracic Society and Joint Indian Chest Society recommend not to use anticholinergic premedication via the parenteral route for preventing cough before bronchoscopy
bronchoscopy A few studies have evaluated inhaled anticholinergic premedication Inoue et al in 1994 studied the effects of inhaled ipratropium bromide on bronchoconstriction in 29 subjects underwent for diagnostic bronchoscopy They concluded that ipratropium protects against the deleterious effects resulting from topical lidocaine anesthesia during bronchoscopy Wang et al evaluated the efficacy of ipratropium bromide in 250 patients in a placebo-controlled trial They reported that nebulized ipratropium bromide could reduce airway secretions and patient discomfort
To our knowledge no study has examined the role of inhaled glycopyrrolate on mucus secretion We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion thereby decreasing cough and thus improving patient comfort during bronchoscopy
In this study we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy
Owing to the lack of clinical benefits and possible hemodynamic changes the British Thoracic Society and Joint Indian Chest Society recommend not to use anticholinergic premedication via the parenteral route for preventing cough before bronchoscopy
bronchoscopy A few studies have evaluated inhaled anticholinergic premedication Inoue et al in 1994 studied the effects of inhaled ipratropium bromide on bronchoconstriction in 29 subjects underwent for diagnostic bronchoscopy They concluded that ipratropium protects against the deleterious effects resulting from topical lidocaine anesthesia during bronchoscopy Wang et al evaluated the efficacy of ipratropium bromide in 250 patients in a placebo-controlled trial They reported that nebulized ipratropium bromide could reduce airway secretions and patient discomfort
To our knowledge no study has examined the role of inhaled glycopyrrolate on mucus secretion We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion thereby decreasing cough and thus improving patient comfort during bronchoscopy
In this study we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None