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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04806438
Enrollment
120
Registered
2021-03-19
Start date
2021-03-21
Completion date
2021-07-21
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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).

Interventions

OTHERGroup A

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

OTHERGroup B

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Global Tolerance ScoreFirst two hours in the postoperative periodThe 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.

Contacts

Primary ContactHeba F Abd El-Aziz Toulan, Lecturer
heba.toulan@gmail.com01221077317
Backup ContactSamar M Abdel Twab Soliman, Lecturer
dr_sm.md@hotmail.com01006236494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026