AzTrials
AzTrials

Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic IntubationNCT05550051

Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns.

A study testing Awake nasal fiberoptic intubation in people with Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic Intubation, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluates the efficacy and ease of lignocaine nebulization to deliver anesthesia to the upper airway of patients with head and neck burns undergoing reconstructive surgery in need of awake nasal fiberoptic intubation compared to the traditional upper airway nerve block. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Awake nasal fiberoptic intubation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
23 Sep 2022to 5 Feb 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients above 18 years with ASA classification II, III, and no known hypersensitivity for local anesthetics

Who cannot join

  • Patient refusal
  • Patients under 18 years
  • Patients suffering from coagulopathies or bleeding tendencies
  • Patients with ASA 4 classification
  • Non cooperative patients
  • Patients undergoing extensive facial reconstruction
  • Patients with known hypersensitivity to lignocaine.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Sameh Refaat

    Cairo, 11728

Other trials in Egypt

About this study

Official title: Lignocaine Nebulization Versus Airway Block for Awake Nasal Fiberoptic Intubation in Patients With Head and Neck Burns. A Randomized Controlled Study.

This study evaluates the efficacy and ease of lignocaine nebulization to deliver anesthesia to the upper airway of patients with head and neck burns undergoing reconstructive surgery in need of awake nasal fiberoptic intubation compared to the traditional upper airway nerve block.

Read the detailed description

Adequate preparation for Awake Fiberoptic Intubation (AFOI) is an art of anesthesia which includes, many methods such as blocking nerves supplying the upper airway including the superior laryngeal, recurrent laryngeal, and glossopharyngeal nerves. Topical anesthesia via a special cannula as you proceed, and lignocaine nebulization. Succeeding in blocking the airway adequately is the first step towards a successful AFOI.

Although many studies have been done to compare the topical anesthesia technique versus the airway block techniques but theses studies have ignored the fact that in many cases of difficult airway indicated for AFOI there is limited or even absent neck mobility, and mouth opening both which are mandatory to perform an adequate airway neural block.

After anesthetizing the airway in both groups either by nebulization or airway block, an anesthesiologist who will be blinded to the study groups will perform the (AFOI) by using an endotracheal tube size 7.5 mm internal diameter endotracheal tube for males and 7 mm for female patients.

Vital signs such as HR, BP, and oxygen saturation (SpO2) will be recorded recorded immediately after intubation and 5 min postintubation and at every 10 minutes during surgery.

The patient response, and satisfaction with the technique will be recorded by using the revised non verbal pain scale (NVPS-R).

The (NVPS-R) is a multidimensional instrument formed of three behavioral (face, activity/movement, and guarding) responses, physiological indicators, and RR.

Patients will be randomly divided into two groups using a computer generated random number chart. Group (AB) will undergo AFOI after performing an airway block prior to the procedure while group (LN) will undergo AFOI after lignocaine nebulization 30 minutes prior to the procedure.

Group (AB) will have an upper airway block by using about lignocaine 2%; the following nerves will be blocked.

Bilateral superior laryngeal nerve block and will be performed after placing the patients in a supine position, with slight neck extension to identify the hyoid bone. Sterilization of the site of injection by 10% povidone iodine will be performed. After identification of the hyoid bone the bone will be move towards the site of injection, where a sterile 25G needle will be inserted laterally aiming at the greater cornu, and after hitting the bone with the needle, it will slide under the bone inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve.

Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by placing the patient supine, with the neck extended to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A 22G needle will be inserted perpendicular to the cricothyroid membrane to penetrate it while aspirating and once air bubbles appear this will mean that we are intra tracheal, then injection of 5ml of 4% lignocaine will result in coughing and dispersing of the LA, blocking the nerve.

While patients in group (LN) will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting.

Being tested
Awake nasal fiberoptic intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Awake nasal fiberoptic intubationProcedure or surgery

    Lignocaine nebulization for upper airway block during awake nasal fiberoptic intubation

Study groups in NCT05550051
Study groupRoleWhat they receive
lignocaine nebulization before awake nasal fiberoptic intubationActive comparatorPatients will have lignocaine nebulization by using 3 ml of lignocaine 2%, with O2 flow rate 10 l/min to deliver 60 mg lignocaine, of which about 25% is absorbed, and patients were encouraged to inhale deeply to facilitate further delivery of the anesthetic in their airway. After finishing the nebulization setting the patient will be asked about facial, nasal, and oral numbness if no numbness, the patient will have another nebulization setting.
Receives: Procedure: Awake nasal fiberoptic intubation
Upper airway block before awake nasal fiberoptic intubationActive comparatorUpper airway block by using about lignocaine 2%, the block will be performed by: 1. Bilateral superior laryngeal nerve block and will be performed by slight neck extension to identify the hyoid bone. Insert the needle laterally aiming at the greater cornu, and after hitting the bone, it will slide inferiorly, and 2 mL of 2% lignocaine will be injected blocking both the internal and the external branches of the superior laryngeal nerve. 2. Trans tracheal instillation for recurrent laryngeal nerve block and will be performed by extending the neck to identify the midline and palpate the cricoid cartilage. The cricothyroid membrane lies above the cricoid cartilage. A needle will be inserted in the cricothyroid membrane while aspirating and once air bubbles appears, 5ml of 4% lignocaine will be injected resulting in cough and dispersing of the LA, blocking the nerve.
Receives: Procedure: Awake nasal fiberoptic intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient comfort during performing awake nasal fiberoptic intubation

    Will be measured by the revised non verbal pain sale

    Measured: 5 minutes

  2. Time to performing awake nasal fiberoptic intubation

    Will be measured by calculating the time to awake nasal fiberoptic intubation

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study start23 Sep 2022
  3. Primary completion2 Feb 2023
  4. Study completion5 Feb 2023

Resources

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
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05550051
Sponsor's protocol ID
R121/2022
Status last verified
Feb 2023
First submitted
19 Sep 2022
Last updated
17 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Awake nasal fiberoptic intubation in people with Practicality, Efficacy, and Ease of Lignocaine Nebulization Compared to Traditional Upper Airway Block for Awake Nasal Fiberoptic Intubation, run by Ain Shams 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 1 inclusion and 7 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 17 Feb 2023. 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. 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?

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?

Patient comfort during performing awake nasal fiberoptic intubation (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 17 Feb 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in