Fiberoptic Bronchoscopy (FOB)Phase 4NCT07743333
Nebulized Lidocaine And Ketamine Before Fiberoptic Bronchoscopy
A Phase 4 study testing Nebulized lidocaine and ketamine, Nebulized Lidocaine and Lidocaine spray (2%) in people with Fiberoptic Bronchoscopy (FOB) and Lung Cancer (Diagnosis), run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fiberoptic Bronchoscopy (FOB), Lung Cancer (Diagnosis), Premedication
- What is being tested?
- Nebulized lidocaine and ketamine, Nebulized Lidocaine and Lidocaine spray (2%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 28 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- history of allergy to lidocaine or ketamine,
- altered mental status, or
- non-corrected coagulopathy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria University Faculty of Medicine
Alexandria, Alexandria Governorate, 21526
About this study
Official title: Nebulized Lidocaine And Ketamine As Premedication Before Fiberoptic Bronchoscopy: A Case-Control Study
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.
Read the detailed description
The investigators conducted a case-control study that randomaly recruited patients planned for bronchoscopy irrespective to the cause. All the patients were recruited from bronchoscopy unit of Alexandria Main University hospital, Egypt. The patients were divided into 3 different groups and were given lidocaine alone (either nebulized or by Spary) or combined nebulized lidocaine-ketamine as premedication before flexible bronchoscopy. The nebulized medications were given by jet-nebulizer. All the patient underwent bronchoscopy under conscious sedation (midazolam, fentanyl with or without propofol) for bronchoalveolar lavage (BAL) with or without biopsy as planned before. All the patients were followed up before, during the bronchoscopy for vital signs (heart rate, blood pressure and O2 saturation "SpO2"), cough during and after the procedure that is scored, discomfort, sedation level using Ramsy sedation level, patient toleranceassessed using 11-point numeric rating scale (NRS) and pain assessed by the verbal rating scale (VRS). The time of the procedure was recorded for comparison. The dose of conscious sedation was calculated for each patient for later comparison. The patients were followed up the 2 hours after bronchoscopy for SpO2, heart rate, blood pressure, level of sedation and satisfaction that was assessed by patient Satisfaction Index (PSI).
- Being tested
- Nebulized lidocaine and ketamine, Nebulized Lidocaine, Lidocaine spray (2%)
- Keywords
- Nebulized Lidocaine, Nebulized Ketamine
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized lidocaine and ketamineDrug
Also called interventional A Group
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.
Nebulized LidocaineDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| interventional A Group | Active comparator | This group of patient were given nebulized lidacaine and ketamine before FOB. Receives: Drug: Nebulized lidocaine and ketamine |
| Interventional B Group | Active comparator | This group of patient were given nebulized lidacaine only before FOB. Receives: Drug: Nebulized Lidocaine |
| Control group | Placebo comparator | This group of patient were given lidacaine spray to the oral and nasal cavity before FOB. Receives: Drug: Lidocaine spray (2%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 2 hours
Secondary outcomes (3)
Sedation effect of nebulized ketamine
The investigators aimed to meaure the sedative effect of ketamine given by nebulization before FOB (secondary to systemic absoption) by Ramsay Sedation Scale, a tool used to assess a patient's level of sedation by observing the patient's behaviour and testing responsiveness during the procedure. The scale is ranging from 1 (anxious) to 6 (no response).
Measured: 2 hours
Comfort of the patient during FOB
The investigators aimed to record the patient comfort during the procedure using the patient satisfaction index through collecting patient feedback after the procedure through a questionnaire. The responses were scored from 1 (best) to 4 (worse).
Measured: 2 hours
Patient tolerance during FOB
The patient tolerance during FOB was measured using 11-point numeric rating scale (NRS) ranging from 0 (completely satisfied) to 10 (completely dissatisfied).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fiberoptic Bronchoscopy (FOB)Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The current study has 3 groups of patients subjected to 3 different methods and drugs before bronchoscopy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Shafiek, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743333
- Sponsor's protocol ID
- 12098
- Other IDs
- Alexandria Faculty of Medicine
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are planning to share IPD but until now the investigators did not decided as they need to talk with all the researchers conducted the trial before it is available for the public. For the time being, the data is available on request from the principal investigator.
Publications
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.
PubMed 27614989Dhooria 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.
PubMed 31299247
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Lidocaine And Ketamine As Premedication Before Fiberoptic Bronchoscopy: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07743333
- Acronym / sponsor ID
- 12098
- Keywords
- Nebulized Lidocaine, Nebulized Ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators conducted a case-control study that randomaly recruited patients planned for bronchoscopy irrespective to the cause. All the patients were recruited from bronchoscopy unit of Alexandria Main University hospital, Egypt. The patients were divided into 3 different groups and were given lidocaine alone (either nebulized or by Spary) or combined nebulized lidocaine-ketamine as premedication before flexible bronchoscopy. The nebulized medications were given by jet-nebulizer. All the patient underwent bronchoscopy under conscious sedation (midazolam, fentanyl with or without propofol) for bronchoalveolar lavage (BAL) with or without biopsy as planned before. All the patients were followed up before, during the bronchoscopy for vital signs (heart rate, blood pressure and O2 saturation "SpO2"), cough during and after the procedure that is scored, discomfort, sedation level using Ramsy sedation level, patient toleranceassessed using 11-point numeric rating scale (NRS) and pain assessed by the verbal rating scale (VRS). The time of the procedure was recorded for comparison. The dose of conscious sedation was calculated for each patient for later comparison. The patients were followed up the 2 hours after bronchoscopy for SpO2, heart rate, blood pressure, level of sedation and satisfaction that was assessed by patient Satisfaction Index (PSI).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The current study has 3 groups of patients subjected to 3 different methods and drugs before bronchoscopy
| Arm | Type | Receives |
|---|---|---|
| interventional A Group | Active comparator | Drug: Nebulized lidocaine and ketamineThis group of patient were given nebulized lidacaine and ketamine before FOB. |
| Interventional B Group | Active comparator | Drug: Nebulized LidocaineThis group of patient were given nebulized lidacaine only before FOB. |
| Control group | Placebo comparator | Drug: Lidocaine spray (2%)This group of patient were given lidacaine spray to the oral and nasal cavity before FOB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized lidocaine and ketamineAlso: interventional A GroupThis 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. | Drug | interventional A Group |
| Nebulized LidocaineThis 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. | Drug | Interventional B Group |
| Lidocaine spray (2%)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. | Drug | Control group |
Primary outcome
Safety of adding ketamine to lidocaine
Time frame: 2 hours
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.
Efficacy of nebulized ketamine to lidocaine
Time frame: 2 hours
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).
Local complication of ketamine and lidocaine
Time frame: 2 hours
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).
3 secondary outcomes
Sedation effect of nebulized ketamine
Time frame: 2 hours
Comfort of the patient during FOB
Time frame: 2 hours
Patient tolerance during FOB
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 27614989Dreher 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.
- Results publication: PubMed 31299247Dhooria 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.
- Individual participant dataSharing planned: Undecided. The investigators are planning to share IPD but until now the investigators did not decided as they need to talk with all the researchers conducted the trial before it is available for the public. For the time being, the data is available on request from the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized lidocaine and ketamine, Nebulized Lidocaine and Lidocaine spray (2%) in people with Fiberoptic Bronchoscopy (FOB) and Lung Cancer (Diagnosis), run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of adding ketamine to lidocaine (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07743333, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.