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

Not Applicable

• Conditions: Anesthesia
• Interventions: Other: Group B; Other: Group A

• Registration Number: NCT04806438
• Lead Sponsor: Ain Shams University

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).

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Study Start: 2021-03-21
• Primary Completion: 2021-06-21
• Study Completion: 2021-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients planned for diagnostic fiberoptic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (nerve block group)	Group B	Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice.
Group A (nebulized lignocaine group)	Group A	Patients will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min

Primary Outcome Measures

Name	Time	Method
Global Tolerance Score	First two hours in the postoperative period	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.