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

NCT04806438 | Unknown

• 1 other identifier: FMASU R128/2020
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Global Tolerance Score

  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.

  First two hours in the postoperative period

Study Arms (2)

Group A (nebulized lignocaine group)

ACTIVE COMPARATOR

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

Other: Group A

Group B (nerve block group)

ACTIVE COMPARATOR

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

Other: Group B

Interventions

Group A OTHER

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

Also known as: Lignocaine nebulizer

Group A (nebulized lignocaine group)

Group B OTHER

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

Also known as: Airway nerve block

Group B (nerve block group)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Heba F Abd El-Aziz Toulan, Lecturer

CONTACT

01221077317; heba.toulan@gmail.com

Samar M Abdel Twab Soliman, Lecturer

CONTACT

01006236494; dr_sm.md@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: March 21, 2021
• Primary Completion: June 21, 2021
• Study Completion: July 21, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03