Anesthesia, Local, Bronchoscopy
Conditions
Keywords
bronchoscopy, lignocaine
Brief summary
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.
Detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as spray as you go method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.
Interventions
DRUG5 sprays of 10% lignocaine
5 sprays of 10% lignocaine
DRUG10 sprays of 10% lignocaine
10 sprays of 10% lignocaine
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Group allocation by opaque sealed envelopes. Participant and bronchoscopist shall be unaware of the number of sprays administered.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adults ≥ 18 yrs of age undergoing flexible bronchoscopy
Exclusion criteria
* Uncontrolled hypertension Systolic Blood Pressure \>180 mm Hg * Symptomatic coronary artery disease * Pregnancy * Not giving informed consent for the procedure * Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3 * Bronchoscopy performed through an artificial airway
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operator rated overall procedure satisfaction | At study completion at approximately 4 months | Visual Analogue Scale score (VAS) between 0 to 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operator rated cough | At study completion at approximately 4 months | Visual Analogue score (VAS) between 0 to 100 |
| Time from bronchoscope introduction to reaching the vocal cords | At study completion at approximately 4 months | Time in seconds |
| Patient willingness to return for repeat bronchoscopy | At study completion at approximately 4 months | Proportion of patients willing for repeat bronchoscopy in each group |
| Cumulative lignocaine dose | At study completion at approximately 4 months | Total dose of lignocaine in milligram (mg) |
| Complications | At study completion at approximately 4 months | Proportion of patients with complications in each group |
Countries
India
Contacts
Primary ContactKaran Madan, MD DM
Backup ContactAnant Mohan, MD
Outcome results
None listed