AnesthesiaNCT04806438
Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation.
A study testing Group A and Group B in people with Anesthesia, run by Ain Shams University.
Trial summary
To compare the effectiveness of nebulization versus airway nerve block technique to achieve upper airway anesthesia for diagnostic fiberoptic bronchoscopy under moderate sedation. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 21 Mar 2021to 21 Jul 2021
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for diagnostic fiberoptic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation. A Randomized Controlled Trial
To compare the effectiveness of nebulization versus airway nerve block technique to achieve upper airway anesthesia for diagnostic fiberoptic bronchoscopy under moderate sedation.
Read the 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).
- Conditions
- Anesthesia
- Being tested
- Group A, Group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called Lignocaine nebulizer
Patient will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min
Group BOther
Also called Airway nerve block
Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice
| Study group | Role | What they receive |
|---|---|---|
| Group A (nebulized lignocaine group) | Active comparator | Patients will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min Receives: 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. Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First two hours in the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start21 Mar 2021 (estimated)
- Primary completion21 Jun 2021 (estimated)
- Study completion21 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806438
- Sponsor's protocol ID
- FMASU R128/2020
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Nerve Block Versus Nebulization by Lignocaine During Diagnostic Flexible Bronchoscopy Under Moderate Sedation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04806438
- Acronym / sponsor ID
- FMASU R128/2020
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Mar 2021 (estimated)
- Primary completion
- 21 Jun 2021 (estimated)
- Study completion
- 21 Jul 2021 (estimated)
- First posted
- 19 Mar 2021 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (nebulized lignocaine group) | Active comparator | Other: Group APatients will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min |
| Group B (nerve block group) | Active comparator | Other: Group BPatients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients planned for diagnostic fiberoptic procedures such as broncho-alveolar lavage, endobronchial or transbronchial biopsies, or brush cytology.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Group AAlso: Lignocaine nebulizerPatient will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min | Other | Group A (nebulized lignocaine group) |
| Group BAlso: Airway nerve blockPatients 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 (nerve block group) |
Primary outcome
Global Tolerance Score
Time frame: First two hours in the postoperative period
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Anesthesia, run by Ain Shams University.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba F Abd El-Aziz Toulan, Lecturer (01221077317 ext. 002, heba.toulan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Tolerance Score (time frame: First two hours in the postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2021.