5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bronchoscopy Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Group allocation by opaque sealed envelopes. Participant and bronchoscopist shall be unaware of the number of sprays administered.

Study Groups

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5 sprays

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

Group Type ACTIVE_COMPARATOR

5 sprays of 10% lignocaine

Intervention Type DRUG

5 sprays of 10% lignocaine

10 sprays

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

Group Type EXPERIMENTAL

10 sprays of 10% lignocaine

Intervention Type DRUG

10 sprays of 10% lignocaine

Interventions

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5 sprays of 10% lignocaine

Intervention Type DRUG

10 sprays of 10% lignocaine

Intervention Type DRUG

Other Intervention Names

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5 sprays 10 sprays

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No