5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03869528
• Other study ID #: 510 RCT
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2021
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: Karan Madan, MD DM
• Phone: 00911126593488
• Email: drkaranmadan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Bronchoscopy

Intervention

Drug:
• 5 sprays of 10% lignocaine
5 sprays of 10% lignocaine
• 10 sprays of 10% lignocaine
10 sprays of 10% lignocaine

Locations

Country	Name	City	State
India	AIIMS	New Delhi
India	AIIMS Rishikesh	Rishikesh

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

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