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

NCT ID: NCT04806438

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-21

Study Completion Date

2021-07-21

Brief Summary

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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

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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).

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A (nebulized lignocaine group)

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

Group Type ACTIVE_COMPARATOR

Group A

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Group B

Intervention Type OTHER

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

Interventions

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Group A

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

Intervention Type OTHER

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

Intervention Type OTHER

Other Intervention Names

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Lignocaine nebulizer Airway nerve block

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Heba F Abd El-Aziz Toulan, Lecturer

Role: CONTACT

01221077317 ext. 002

Samar M Abdel Twab Soliman, Lecturer

Role: CONTACT

01006236494 ext. 002

Other Identifiers

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FMASU R128/2020

Identifier Type: -

Identifier Source: org_study_id

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