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Not yet recruitingNCT07139730Updated Aug 24, 2025

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

An interventional study of Lignocaine 2% concentration solution in Stress Response, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
1 Year to 9 Years
Sex
All
01

Study 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 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) .

02

Conditions studied

  • Stress Response

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03

In context

Fractures, Stress

168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.

This study's planned enrollment of 70 is close to the median of 66 across 134 interventional studies indexed under Fractures, Stress.

Browse Fractures, Stress studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria: 1. Elective tonsillectomy operation 2- pediaterics below 9 years old 3- ASA I OR II

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Exclusion Criteria: 1- emergency cases as bleeding tonsills 2- ASA III OR IV

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Effect of Nebulized Lignocaine on the stress Response of Endotracheal Intubation in pediatrics unde

    Drug: Lignocaine 2% concentration solution

Interventions

  • DrugLignocaine 2% concentration solution

    the effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation

06

What researchers measure

Primary outcomes

  1. effect on serum cortisol level 2 minutes after intubation

    Time frame: baseline

  2. effect on serum cortisol level 2 minutes after intubation

    effect on serum cortisol level 2 minutes after intubation to asses decrease in stress response

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07139730
Lead sponsor
Assiut University
Responsible party
Mahmoud Sayed Frag Ahmed (doctor, Assiut University) — Principal investigator
First posted
Aug 24, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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