1% vs. 2 % Lignocaine for Flexible Bronchoscopy (LIFE)

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Diseases
• Intervention / Treatment: Drug: Lignocaine 1% concentration solution; Drug: Lignocaine 2% concentration solution

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110029
    • All India Institute Of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Indication for diagnostic or therapeutic flexible bronchoscopy
2. Age > 18 years
3. Hemodynamic stability (defined as systolic BP >100 mm Hg and, <180 mm Hg).

Exclusion Criteria:

1. Refusal of consent
2. Known documented hypersensitivity to lignocaine
3. Procedure performed under general anaesthesia or sedation
4. Pregnancy
5. Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
6. Bronchoscopy done through endotracheal or tracheostomy tube

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 % Lignocaine; 1 % Lignocaine administered for topical anaesthesia during bronchoscopy procedure	Drug: Lignocaine 1% concentration solution
Active Comparator: 2 % Lignocaine; 2 % Lignocaine administered for topical anaesthesia during bronchoscopy procedure	Drug: Lignocaine 2% concentration solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Operator rated cough VAS	At study completion approximately 12 months
Operator rated overall procedure satisfaction VAS	At study completion approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total lignocaine dose administered	At study completion approximately 12 months
Patient facies pain rating scale	At study completion approximately 12 months
Procedure related adverse events	At study completion approximately 12 months

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Study Chair: Randeep Guleria, MD, DM, All India Institute of Medical Sciences, New Delhi

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Lignocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Pharmaceutical Solutions
• Other Study ID Numbers: Lignocaine RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No