Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ain Shams University
- Enrollment
- 120
- Primary Endpoint
- Global Tolerance Score
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A (nebulized lignocaine group)
Patients will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min
Intervention: Group A (Other)
Group B (nerve block group)
Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice.
Intervention: Group B (Other)
Outcomes
Primary Outcomes
Global Tolerance Score
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported