5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

January 13, 2021 updated by: Karan Madan, All India Institute of Medical Sciences, New Delhi

A Randomized Controlled Trial to Evaluate the Efficacy of Topical Pharyngeal Anaesthesia Using 5 vs 10 Sprays of 10% Lignocaine During 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.

Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as "spray as you go" method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • All adults ≥ 18 yrs of age undergoing flexible bronchoscopy

Exclusion Criteria:

  • Uncontrolled hypertension Systolic Blood Pressure >180 mm Hg
  • Symptomatic coronary artery disease
  • Pregnancy
  • Not giving informed consent for the procedure
  • Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
  • Bronchoscopy performed through an artificial airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5 sprays
5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy
Drug: 5 sprays of 10% lignocaine
5 sprays of 10% lignocaine
Other Names:
  • 5 sprays
Experimental: 10 sprays
10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy
Drug: 10 sprays of 10% lignocaine
10 sprays of 10% lignocaine
Other Names:
  • 10 sprays

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator rated overall procedure satisfaction
Time Frame: At study completion at approximately 4 months
Visual Analogue Scale score (VAS) between 0 to 100
At study completion at approximately 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator rated cough
Time Frame: At study completion at approximately 4 months
Visual Analogue score (VAS) between 0 to 100
At study completion at approximately 4 months
Time from bronchoscope introduction to reaching the vocal cords
Time Frame: At study completion at approximately 4 months
Time in seconds
At study completion at approximately 4 months
Patient willingness to return for repeat bronchoscopy
Time Frame: At study completion at approximately 4 months
Proportion of patients willing for repeat bronchoscopy in each group
At study completion at approximately 4 months
Cumulative lignocaine dose
Time Frame: At study completion at approximately 4 months
Total dose of lignocaine in milligram (mg)
At study completion at approximately 4 months
Complications
Time Frame: At study completion at approximately 4 months
Proportion of patients with complications in each group
At study completion at approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Study Chair: Randeep Guleria, MD DM, AIIMS, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 510 RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia, Local

Clinical Trials on 5 sprays of 10% lignocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe