Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia

Status Completed

Clinical Trial 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 transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during bronchoscopy. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.

Clinical Trial 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 transcricoid or spray as you go 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 initial route of lignocaine delivery.

During the procedure, 1.5 ml aliquots of 2% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution instilled transtracheally along with two baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. 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. Cough count shall be noted. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02981277
Study type	Interventional
Source	All India Institute of Medical Sciences, New Delhi
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2016
Completion date	March 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Bronchoscopy — CRISP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms