A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
Sponsor study identifier
interventional
1,050
1 country
1
Study Start
May 1, 2017
Actual (reported)Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 29, 2017
Actual (reported)April 12, 2017
Actual (reported)May 1, 2017
Actual (reported)June 30, 2018
Actual (reported)June 30, 2018
Actual (reported)Patient-rated intensity of cough on a visual analog scale (VAS)
The cough VAS is a 100-mm scale anchored by no cough on one end and worst cough on the other; the patient will indicate the severity of a cough by marking a line.
One hour
Pain assessment by the patient using the faces pain rating scale
One hour
Patient-rated VAS of overall satisfaction of the procedure
One hour
Operator-rated intensity of cough on a VAS
Immediately following the procedure
Total lignocaine dose
Immediately following the procedure
Changes in respiratory rate following the procedure
Baseline and 5 minutes after the procedure
2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy
10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy
10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
Bronchoscopy suite, PGIMER
Chandigarh, 160012, India
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.
1,050 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2017
First Posted
April 12, 2017
Study Start
May 1, 2017
Actual (reported)Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients
Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Last Updated
February 23, 2021
Record last verified: 2021-02
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