A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy

NCT ID: NCT06376942

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2025-06-15

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.

Conditions

Subjects Undergoing Flexible Bronchoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Glycopyrronium

Nebulized glycopyrronium 50 mcg (2 ml) administered via a jet nebulizer over 10 minutes

Group Type: EXPERIMENTAL

Glycopyrronium

Intervention Type: DRUG

Nebulized glycopyrronium 50 mcg

Ipratropium

Nebulized ipratropium bromide 500 mcg (2 ml) administered via a jet nebulizer over 10 minutes

Group Type: ACTIVE_COMPARATOR

Ipratropium

Intervention Type: DRUG

Nebulized iptratropium 500 mcg

Saline

Nebulized saline 0.9% (2 ml) administered via a jet nebulizer over 10 minutes

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

0.9% saline 2 ml

Interventions

Glycopyrronium

Nebulized glycopyrronium 50 mcg

Intervention Type: DRUG

Ipratropium

Nebulized iptratropium 500 mcg

Intervention Type: DRUG

Saline

0.9% saline 2 ml

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age ≥18 years
• hemodynamically stable
• willing to provide a written informed consent

Exclusion Criteria

• intubated or tracheostomized patients
• patients with airway stent in situ
• patients with a history of glaucoma
• baseline oxygen saturation <90%
• patients with hemodynamic instability (SBP <90 mm Hg)
• patients undergoing sedation for bronchoscopy
• failure to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ritesh Agarwal

Professor of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bronchoscopy suite, PGIMER

Chandigarh, , India

Countries

India

Central Contacts

Ritesh Agarwal

Role: CONTACT

agarwal.ritesh@outlook.in

7087007625

Inderpaul Sehgal

Role: CONTACT

inderpgi@outlook.com

7087007625

Other Identifiers

Int/IEC/2024/SPL-5

Identifier Type: -

Identifier Source: org_study_id