Clinical trial NCT03869528: 5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchoscopy
Anesthesia, Local
Keywords: bronchoscopy
lignocaine
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operator rated overall procedure satisfaction
timeFrame: At study completion at approximately 4 months
Secondary outcomes:
measure: Operator rated cough
timeFrame: At study completion at approximately 4 months
measure: Time from bronchoscope introduction to reaching the vocal cords
timeFrame: At study completion at approximately 4 months
measure: Patient willingness to return for repeat bronchoscopy
timeFrame: At study completion at approximately 4 months
measure: Cumulative lignocaine dose
timeFrame: At study completion at approximately 4 months
measure: Complications
timeFrame: At study completion at approximately 4 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
city: Rishīkesh
country: India
facility: AIIMS Rishikesh
Study officials:
affiliation: AIIMS, New Delhi
name: Randeep Guleria, MD DM
role: STUDY_CHAIR
References: