Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation.

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of nebulization versus airway nerve block technique to achieve upper airway anesthesia for diagnostic fiberoptic bronchoscopy under moderate sedation.

Detailed Description
-----------------
Randomization was done using computer generated tables of random numbers: Group A (nebulized lignocaine group) as a control group (n = 60) received 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min . Group B (nerve block group) (n = 60) received bilateral superior laryngeal nerve block and trans-tracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice. Patient tolerance was assessed using the Global Tolerance Score, based on a visual analogue scale ( VAS).

Official Title
-----------------
Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation. A Randomized Controlled Trial

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: Group A
* Other: Group B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned for diagnostic fiberoptic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology. Exclusion Criteria: Patients less than 21yrs old and patients more than 70 yrs old. Severe respiratory failure (pH < 7.35, partial arterial oxygen pressure <55 mmHg despite supplemental oxygen). Upper airway surgery or radiation, allergy to lidocaine, Propofol or midazolam, or bleeding disorder. Hemodynamic instable patient or patient decompensated heart failure. Epileptic patients, severe neurological or psychiatric disorder. Patients requiring cryo-biopsy or endobronchial ultrasound because these procedures are performed under deep sedation including fiberoptic intubation.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (nebulized lignocaine group)<br>Patients will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min | Other: Group A<br>* Patient will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min<br>* Other names: Lignocaine nebulizer;|
| Active Comparator: Group B (nerve block group)<br>Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice. | Other: Group B<br>* Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice<br>* Other names: Airway nerve block;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Tolerance Score | The Tolerance Score, defined as the arithmetic mean of global tolerance visual analogue score (VAS)and the mean of scores for the 4 specific sensations, was calculated. | First two hours in the postoperative period |