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Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Phase 3 trial testing Topical lidocaine in Bronchiectasis Adult in 29 participants. Terminated before completion.
| Lead sponsor | Milton S. Hershey Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 1 April 2019 |
| Primary completion | 31 August 2020 |
| Estimated completion | 31 August 2020 |
| Sites | 1 location across United States |
Milton S. Hershey Medical Center
18 and older, any sex, with Bronchiectasis Adult or Mediastinal Lymphadenopathy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 1.20 | ± 1.70 |
| Nebuliser Solution | 1.71 | ± 1.60 |
| Atomizer Solution | 1.00 | ± 1.00 |
sore throat was self reported by patient as: none, mild, moderate, severe
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 6 | |
| Nebuliser Solution | 4 | |
| Atomizer Solution | 2 | |
| Topical Lidocaine | 4 | |
| Nebuliser Solution | 0 | |
| Atomizer Solution | 3 | |
| Topical Lidocaine | 1 | |
| Nebuliser Solution | 2 | |
| Atomizer Solution | 1 | |
| Topical Lidocaine | 0 | |
| Nebuliser Solution | 0 | |
| Atomizer Solution | 0 |
Subjective cough as described by patient as: none, mild, moderate, severe
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 1 | |
| Nebuliser Solution | 1 | |
| Atomizer Solution | 2 | |
| Topical Lidocaine | 8 | |
| Nebuliser Solution | 4 | |
| Atomizer Solution | 3 | |
| Topical Lidocaine | 2 | |
| Nebuliser Solution | 1 | |
| Atomizer Solution | 1 | |
| Topical Lidocaine | 0 | |
| Nebuliser Solution | 0 | |
| Atomizer Solution | 0 |
time in minutes from scope out until ready for transport to post anesthesia care unit
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 8.47 | ± 4.02 |
| Nebuliser Solution | 13.00 | ± 5.77 |
| Atomizer Solution | 6.14 | ± 3.80 |
Total alfentanyl dosing by anesthesia in mcg/kg
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 16.61 | ± 22.64 |
| Nebuliser Solution | 47.99 | ± 37.41 |
| Atomizer Solution | 4.40 | ± 7.42 |
Total propofol dosing by anesthesia in mg/kg
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 5.30 | ± 3.23 |
| Nebuliser Solution | 6.93 | ± 3.36 |
| Atomizer Solution | 3.26 | ± 0.81 |
total fentanyl dosing by anesthesia in mcg/kg
| Group | Value | 95% CI |
|---|---|---|
| Topical Lidocaine | 0.30 | ± 0.28 |
| Nebuliser Solution | 0.24 | ± 0.23 |
| Atomizer Solution | 0.48 | ± 0.39 |
The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.
No peer-reviewed publications indexed yet for this trial.
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