Clinical trial NCT03109392: A Randomized Trial of 4% Nebulized Lignocaine vs. 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
Official title: A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Patients With Indication for Flexible Bronchoscopy
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-04-12
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.

Detailed description: Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. The bronchoscope can be used to sample material not only from the visualized regions but also from the more distal pulmonary parenchyma. It is a safe outpatient exam that carries little risk. While performing the procedure most of the patients express some fear of pain, difficulty in breathing, nasopharyngeal irritation, and cough. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. Administration of a topical anaesthetic drug to the upper airway, larynx, and tracheobronchial tree can reduce a cough and patient's discomfort. The most commonly used topical anaesthetic agent in bronchoscopy is lignocaine because of its quick onset and short duration of action with decreased toxicity as compared to other agents. There are several ways to achieve topical anaesthesia in flexible bronchoscopy including nebulization, direct spray, by tracheal injection, or via nasal, or "spray as you go" technique through the working channel of the bronchoscope. The use of topical anaesthesia, sedation, and analgesia during flexible bronchoscopy varies according to physicians, institutions and geographic locations in the world. Generally, moderate sedation is used in bronchoscopy in which patients can respond to verbal commands. Deep sedation is less commonly used in which patients cannot be easily aroused but respond to repeated or painful stimulation.

Antoniades et al. demonstrated that topical lidocaine through the bronchoscope significantly decreased cough frequency and the total dose of sedation required during flexible bronchoscopy. In a randomized controlled trial of 54 patients, Keane et al. concluded that nebulized and sprayed lignocaine have similar efficacy as topical anaesthetics in fiberoptic bronchoscopy but patients preferred the nebulized route. Noitasaeng et.al. concluded in their study that spraying lidocaine took less time to start the procedure, with greater ease of instrumentation, less incidence of hypersecretion, less gag reflex, and smooth operation during the procedure but patients preferred nebulized lidocaine administration.

At the investigators' center, it has been a routine practice to perform flexible bronchoscopy without sedation in patients who require only diagnostic flexible bronchoscopy and assessment of airway anatomy and other routine procedures such as endobronchial biopsy or transbronchial biopsy. Previously, the investigators had shown that 1% lignocaine given by spray-as-you-go method was similar in efficacy to 2% lignocaine for topical anesthesia during routine flexible bronchoscopy. However, in this study both the groups received nebulized lignocaine and lignocaine spray prior to flexible bronchoscopy in addition to lignocaine solution ad lib.

The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Willing for flexible bronchoscopy procedure a

Exclusion Criteria:

* Requirement of intravenous sedation to undergo any procedure including EBUS-TBNA, conventional TBNA, radial EBUS procedure and interventional pulmonary procedures
* Sensitivity to lignocaine
* Hemodynamically unstable patients (SBP \< 90 mm Hg)
* Baseline hypoxemia (SpO2 \<92% on room air)
* Pregnancy
* Comorbid illness such as heart failure, CKD, chronic liver disease and others
* Failure to provide informed consent

Primary outcomes:
measure: Patient-rated intensity of cough on a visual analog scale (VAS)
timeFrame: One hour
Secondary outcomes:
measure: Pain assessment by the patient using the faces pain rating scale
timeFrame: One hour
measure: Patient-rated VAS of overall satisfaction of the procedure
timeFrame: One hour
measure: Operator-rated intensity of cough on a VAS
timeFrame: Immediately following the procedure
measure: Total lignocaine dose
timeFrame: Immediately following the procedure
measure: Changes in respiratory rate following the procedure
timeFrame: Baseline and 5 minutes after the procedure
measure: Changes in heart rate following the procedure
timeFrame: Baseline, during and 5 minutes after the procedure
measure: Changes in blood pressure following the procedure
timeFrame: Baseline and 5 minutes after the procedure
measure: Changes in oxygenation status following the procedure
timeFrame: Baseline, during and 5 minutes after the procedure
measure: Duration of procedure (in minutes)
timeFrame: Immediately following the completion of flexible bronchoscopy
measure: Willingness of the patient to undergo the procedure yet again, if required
timeFrame: One hour
measure: Adverse reactions related to lignocaine
timeFrame: One hour
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Bronchoscopy suite, PGIMER
Study officials:
References:
citation: Dhooria S, Chaudhary S, Ram B, Sehgal IS, Muthu V, Prasad KT, Aggarwal AN, Agarwal R. A Randomized Trial of Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy. Chest. 2020 Jan;157(1):198-204. doi: 10.1016/j.chest.2019.06.018. Epub 2019 Jul 9.