Clinical Trials Directory

Trials / Completed

CompletedNCT02701179

1% vs. 2 % Lignocaine for Flexible Bronchoscopy

Comparison of 1% Versus 2% Lignocaine for Topical Anaesthesia in Flexible Bronchoscopy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
500 (actual)
Sponsor
All India Institute of Medical Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 lower concentrations (1%) versus a higher (2%) during bronchoscopic procedures. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for 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 1% lignocaine or 2% lignocaine 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 concentration of lignocaine used. Two different concentration of lignocaine solution will be labelled as solution 'A' or solution 'B' containing either of 1% or 2% lignocaine solution .Operator will be provided either solution A or B based on the initial randomisation. During the procedure, 1.5ml aliquots of the provided lignocaine solution will be delivered through the bronchoscope using spray-as-you go technique. The total number of aliquots used 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. Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Conditions

Interventions

TypeNameDescription
DRUGLignocaine 1% concentration solution
DRUGLignocaine 2% concentration solution

Timeline

Start date
2016-04-01
Primary completion
2017-03-01
Completion
2017-03-01
First posted
2016-03-08
Last updated
2017-08-22

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT02701179. Inclusion in this directory is not an endorsement.