Stress ResponseNCT07139730
Effect of Nebulized Lignocaine on the Stress Response of Endotracheal Intubation in Pediatrics Undergoing Tonsillectomy Operation Monitored by Rise in Serum Cortisol Level Post Intubation
A study testing Lignocaine 2% concentration solution in people with Stress Response, run by Assiut University.
Trial summary
This randomized clinical trial aims to is examining the effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation Read more about this study
- Who is it for?
- Ages 1 year to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Response
- What is being tested?
- Lignocaine 2% concentration solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: 1. Elective tonsillectomy operation 2- pediaterics below 9 years old 3- ASA I OR II
-
Exclusion Criteria: 1- emergency cases as bleeding tonsills 2- ASA III OR IV
About this study
Official title: Effect of Nebulized Lignocaine on the Stress Response of Endotracheal Intubation in Pediatrics Undergoing Tonsillectomy Operation ; A Randomized Controlled Clinical Trial
This randomized clinical trial aims to is examining the effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation
Read the detailed description
Endotracheal intubation is a routine and often critical procedure performed in patients who require airway management, particularly during surgeries, emergency interventions, or in cases of respiratory failure. While essential, the process of intubation can provoke significant hemodynamic changes in patients, including fluctuations in heart rate, blood pressure, and other vital parameters. These hemodynamic responses are primarily a result of the stimulation caused by the mechanical manipulation of the airway and the associated stress response. (1,2).
The stress response to intubation is mainly mediated by the sympathetic nervous system, leading to an increase in catecholamine release, which in turn causes an elevation in heart rate and blood pressure. In certain vulnerable populations, such as those with pre-existing cardiovascular conditions, these changes can be problematic and increase the risk of complications such as arrhythmias, myocardial ischemia, and cerebrovascular events. (2, 3).
Lignocaine is a local anesthetic that has been shown to have antiarrhythmic properties and can be administered through various routes to reduce the stress response associated with endotracheal intubation. It can be delivered intravenously or via inhalation through a nebulizer. The intravenous route (IV) is commonly used in clinical practice to provide systemic analgesia and reduce sympathetic stimulation. Nebulized lignocaine, on the other hand, delivers the drug directly to the airway and has been proposed as a potential alternative for reducing the hemodynamic impact of intubation while also minimizing systemic side effects. (4,5,6).
Previous studies have suggested that both intravenous and nebulized lignocaine may be effective in attenuating the hemodynamic response to intubation. However, there remains a gap in understanding regarding the comparative efficacy, optimal dosing, and side-effect profiles of these two administration methods. While both approaches have been used in various clinical settings, there has been limited research examining their direct effects and comparison in a controlled, randomized trial setting. (7) .
- Conditions
- Stress Response
- Being tested
- Lignocaine 2% concentration solution
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lignocaine 2% concentration solutionDrug
the effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation
| Study group | Role | What they receive |
|---|---|---|
| Effect of Nebulized Lignocaine on the stress Response of Endotracheal Intubation in pediatrics unde | Experimental | Not described Receives: Drug: Lignocaine 2% concentration solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on serum cortisol level 2 minutes after intubation
Measured: baseline
effect on serum cortisol level 2 minutes after intubation
effect on serum cortisol level 2 minutes after intubation to asses decrease in stress response
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ResponseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sayed Frag Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139730
- Sponsor's protocol ID
- stress Response of ETT
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- 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 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Lignocaine on the Stress Response of Endotracheal Intubation in Pediatrics Undergoing Tonsillectomy Operation ; A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07139730
- Acronym / sponsor ID
- stress Response of ETT
- Conditions
- Stress Response
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Aug 2025 (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.
This randomized clinical trial aims to is examining the effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation
Detailed description
Endotracheal intubation is a routine and often critical procedure performed in patients who require airway management, particularly during surgeries, emergency interventions, or in cases of respiratory failure. While essential, the process of intubation can provoke significant hemodynamic changes in patients, including fluctuations in heart rate, blood pressure, and other vital parameters. These hemodynamic responses are primarily a result of the stimulation caused by the mechanical manipulation of the airway and the associated stress response. (1,2).
The stress response to intubation is mainly mediated by the sympathetic nervous system, leading to an increase in catecholamine release, which in turn causes an elevation in heart rate and blood pressure. In certain vulnerable populations, such as those with pre-existing cardiovascular conditions, these changes can be problematic and increase the risk of complications such as arrhythmias, myocardial ischemia, and cerebrovascular events. (2, 3).
Lignocaine is a local anesthetic that has been shown to have antiarrhythmic properties and can be administered through various routes to reduce the stress response associated with endotracheal intubation. It can be delivered intravenously or via inhalation through a nebulizer. The intravenous route (IV) is commonly used in clinical practice to provide systemic analgesia and reduce sympathetic stimulation. Nebulized lignocaine, on the other hand, delivers the drug directly to the airway and has been proposed as a potential alternative for reducing the hemodynamic impact of intubation while also minimizing systemic side effects. (4,5,6).
Previous studies have suggested that both intravenous and nebulized lignocaine may be effective in attenuating the hemodynamic response to intubation. However, there remains a gap in understanding regarding the comparative efficacy, optimal dosing, and side-effect profiles of these two administration methods. While both approaches have been used in various clinical settings, there has been limited research examining their direct effects and comparison in a controlled, randomized trial setting. (7) .
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of Nebulized Lignocaine on the stress Response of Endotracheal Intubation in pediatrics unde | Experimental | Drug: Lignocaine 2% concentration solution |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Lignocaine 2% concentration solutionthe effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation | Drug | Effect of Nebulized Lignocaine on the stress Response of Endotracheal Intubation in pediatrics unde |
Primary outcome
effect on serum cortisol level 2 minutes after intubation
Time frame: baseline
effect on serum cortisol level 2 minutes after intubation
Time frame: baseline
effect on serum cortisol level 2 minutes after intubation to asses decrease in stress response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine 2% concentration solution in people with Stress Response, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
effect on serum cortisol level 2 minutes after intubation (time frame: baseline). 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 24 Aug 2025.