5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

All India Institute Of Medical Science (AIIMS)

Status: Unknown

Conditions: Anesthesia, Local; Bronchoscopy

Treatments: Drug: 10 sprays of 10% lignocaine; Drug: 5 sprays of 10% lignocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03869528

510 RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

5 sprays

Active Comparator group

Description:

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

Treatment:

Drug: 5 sprays of 10% lignocaine

10 sprays

Experimental group

Description:

10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy

Treatment:

Drug: 10 sprays of 10% lignocaine