5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

Not Applicable

• Conditions: Bronchoscopy; Anesthesia, Local
• Interventions: Drug: 5 sprays of 10% lignocaine; Drug: 10 sprays of 10% lignocaine

• Registration Number: NCT03869528
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Brief 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.

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 Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-04-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 sprays	5 sprays of 10% lignocaine	5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy
10 sprays	10 sprays of 10% lignocaine	10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy

Primary Outcome Measures

Name	Time	Method
Operator rated overall procedure satisfaction	At study completion at approximately 4 months	Visual Analogue Scale score (VAS) between 0 to 100

Secondary Outcome Measures

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

Trial Locations

Locations (2)

AIIMS; 🇮🇳 New Delhi, India

AIIMS Rishikesh; 🇮🇳 Rishīkesh, India