Clinical trial NCT03040193: Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial
Official title: Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Disease
Keywords: Lignocaine
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.

Detailed description: For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation.

During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.

Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Eligibility criteria: Inclusion Criteria:

* Adult (Age \> 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy

Exclusion Criteria:

1. Pregnancy
2. Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
3. Bronchoscopy done through endotracheal or tracheostomy tube
4. Not willing to provide informed consent.
5. Patient requiring sedation for flexible bronchoscopy
6. Patients with known allergy to lignocaine -

Primary outcomes:
measure: Operator rated overall procedure satisfaction VAS
timeFrame: At study completion approx. 12 months
measure: Operator rated cough VAS
timeFrame: At study completion approx. 12 months
Secondary outcomes:
measure: Total dose of Lignocaine administered (mg)
timeFrame: At study completion approx. 12 months
measure: Number of patients receiving dose >8.2mg/Kg
timeFrame: At study completion approx. 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
Study officials:
affiliation: AIIMS, New Delhi
name: Randeep Guleria, MD, DM
role: STUDY_CHAIR
References: