Nebulized Lidocaine And Ketamine Before Fiberoptic Bronchoscopy

NCT07743333 | Completed Phase 4 DMC

• 2 other identifiers: 12098Alexandria Faculty of Medicine
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is looked for the comparison between nebulized lidocaine and ketamine, nebulized lidocaine, and usual lidocaine spray in the oral and nasal cavities before flexible bronchoscopy. The investigators are looking for different outcomes including mainly cough suppression during the procedure, patient tolerance and discomfort, operator and patients' satisfaction, and safety of the use of these medications especially regarding nebulized ketamine.

Conditions

Fiberoptic Bronchoscopy (FOB); Lung Cancer (Diagnosis); Premedication

Keywords

Nebulized Lidocaine; Nebulized Ketamine

Outcome Measures

Primary Outcomes (3)

• Safety of adding ketamine to lidocaine

  The investigators aimed to record the systemic side effects of combined nebulization of ketamine and lidocaine especially regarding heamodynamic stability (measurement of blood pressure) just after giving the nebulization and over 2 hours.

  2 hours

• Efficacy of nebulized ketamine to lidocaine

  The investigators aimed to measure the efficacy of combined lidocaine and ketamine vs. lidocaine alone as premedication of FOB regarding suppressing cough during the procedure using the cough score. The cough score, a simple assessment tool based on patient experience, was used to grade airway irritation from 0 (none) to 4 (severe).

  2 hours

• Local complication of ketamine and lidocaine

  After use of the medications, local side effects were records and assessed using the verbal rating scale (VRS), a method for assessing pain, in which patients were asked to describe their pain on a scale from 0 (none) to 3 (severe).

  2 hours

Secondary Outcomes (3)

• Sedation effect of nebulized ketamine

  2 hours

• Comfort of the patient during FOB

  2 hours

• Patient tolerance during FOB

  2 hours

Study Arms (3)

interventional A Group

ACTIVE COMPARATOR

This group of patient were given nebulized lidacaine and ketamine before FOB.

Drug: Nebulized lidocaine and ketamine

Interventional B Group

ACTIVE COMPARATOR

This group of patient were given nebulized lidacaine only before FOB.

Drug: Nebulized Lidocaine

Control group

PLACEBO COMPARATOR

This group of patient were given lidacaine spray to the oral and nasal cavity before FOB.

Drug: Lidocaine spray (2%)

Interventions

Nebulized lidocaine and ketamine DRUG

This group received nebulization of lidocaine (dose of 60 mg) and ketamine (dose of 150 mg) each in separate nebulization before FOB as premedication. The patients were followed up before (just after nebulization), during and after FOB regarding hemodynamic satbility (as measured by blood pressure), heart rate and oxygen saturation.

Also known as: interventional A Group

interventional A Group

Nebulized Lidocaine DRUG

This group received nebulization of lidocaine (dose of 60 mg) only before FOB as premedication. The patients were followed up before, during and after FOB regarding hemodynamic satbility (measured by blood pressure), heart rate and O2 saturation.

Interventional B Group

Lidocaine spray (2%) DRUG

This group received lidocaine spray (2%) alone for the oral and nasal cavities before FOB as premedication. The patients were followed up before, during and after FOB regarding hemodynamic satbility (measured by blood pressure), heart rate and O2 saturation.

Control group

Eligibility Criteria

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

You may qualify if:

• All patients were assigned for FOB for diagnostic causes as part of their usual care.
• All patients were assigned for FOB for therapeutic causes as part of their usual care.

You may not qualify if:

• unstable angina or recent myocardial infarction,
• hypoxemia that is not corrected by oxygen therapy,
• increased intracranial pressure or recent cerebrovascular stroke,
• uncontrolled uraemia,
• uncontrolled hypertension,
• current viral infections or colds,
• history of allergy to lidocaine or ketamine,
• altered mental status, or
• non-corrected coagulopathy

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicine

Alexandria, Alexandria Governorate, 21526, Egypt

Location

Related Publications (2)

• Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.

  PMID: 27614989 RESULT

• Dhooria S, Chaudhary S, Ram B, Sehgal IS, Muthu V, Prasad KT, Aggarwal AN, Agarwal R. A Randomized Trial of Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy. Chest. 2020 Jan;157(1):198-204. doi: 10.1016/j.chest.2019.06.018. Epub 2019 Jul 9.

  PMID: 31299247 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Disease

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: The current study has 3 groups of patients subjected to 3 different methods and drugs before bronchoscopy

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 3, 2026
• Study Start: September 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

EG (1)