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

Ain Shams University

Status: Unknown

Conditions: Anesthesia

Treatments: Other: Group A; Other: Group B

Study type: Interventional

Funder types: Other

Identifiers

NCT04806438

FMASU R128/2020

Details and patient eligibility

About

To compare the effectiveness of nebulization versus airway nerve block technique to achieve upper airway anesthesia for diagnostic fiberoptic bronchoscopy under moderate sedation.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Group A (nebulized lignocaine group)

Active Comparator group

Description:

Patients will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min

Treatment:

Other: Group A

Group B (nerve block group)

Active Comparator group

Description:

Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice.

Treatment:

Other: Group B