Anesthesia Intubation ComplicationLA-STEROIDNCT04085744
A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff
A study testing Lidocaine 10% Spray and Mometasone nasal spray in people with Anesthesia Intubation Complication and Intubation Complication, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Anesthesia Intubation Complication, Intubation Complication, Sore Throat
- What is being tested?
- Lidocaine 10% Spray and Mometasone nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 15 Jun 2020
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being ages between 2 and 18
- undergoing elective surgery
- intubated patients over 1 hour
- ASA(American Society of Anesthesiologists) Class I-II patients
Who cannot join
- Urgent surgeries
- Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health and Science University Derince Training and Research Hospital
Derince, Kocaeli, 41900
About this study
Official title: A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients
This study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.
Read the detailed description
In the literature there were studies about both local anesthetic agents and topical steroids and different densities of saline which were applied to decrease airway complications. In this study researchers intended to compare effects of local anesthetic agents and topical steroids applying around tracheal tube on airway complications which may occur in the first 24 hours after surgery. All pediatric patients scheduled for elective surgery will be recruited. enrolled patients will randomly assigned in to three groups: Control group, local anesthetic group and topical steroid group.
- Being tested
- Lidocaine 10% Spray, Mometasone nasal spray
- Keywords
- intubation, anesthesia, corticosteroids, lidocaine, complication of intubation
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 10% SprayDrug
Also called lidocaine
lidocaine will be apply on the cuff
Mometasone nasal sprayDrug
Also called steroid
mometasone spray will be applied on the cuff
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | In this group any drug will be applied on the cuff of the intubation tube |
| lidocaine group | Active comparator | 10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated. Receives: Drug: Lidocaine 10% Spray |
| steroid group | Active comparator | mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated. Receives: Drug: Mometasone nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) for pain
Self Reported VAS at postoperative unit. VAS 0 is no pain VAS 10 is pain as bad as can be
Measured: 1 hour
Visual analog scale (VAS) for pain
Self reported VAS postoperative at hour 6. VAS 0 is no pain VAS 10 is pain as bad as can be
Measured: 6 hours
Visual analog scale (VAS) for pain
Self reported VAS postoperative at hour 12. VAS 0 is no pain VAS 10 is pain as bad as can be
Measured: 12 hours
Visual analog scale (VAS) for pain
Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Nov 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALI ULVI OLC, Derince Training and Research Hospital
- Investigators
- Ayse Z Turan, Study director, HEALTH AND SCİENCE UNIVERSITY DERINCE TRAINING AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085744
- Sponsor's protocol ID
- AOLC-1
- Acronym
- LA-STEROID
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04085744
- Acronym / sponsor ID
- LA-STEROID / AOLC-1
- Keywords
- intubation, anesthesia, corticosteroids, lidocaine, complication of intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 11 Sep 2019 (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 study aims to compare effects of two different agents on complications due to tracheal tube cuff in pediatric patients. Sore throat, hoarseness, laryngospasm, bronchospasm are the main complications.
Detailed description
In the literature there were studies about both local anesthetic agents and topical steroids and different densities of saline which were applied to decrease airway complications. In this study researchers intended to compare effects of local anesthetic agents and topical steroids applying around tracheal tube on airway complications which may occur in the first 24 hours after surgery. All pediatric patients scheduled for elective surgery will be recruited. enrolled patients will randomly assigned in to three groups: Control group, local anesthetic group and topical steroid group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –In this group any drug will be applied on the cuff of the intubation tube |
| lidocaine group | Active comparator | Drug: Lidocaine 10% Spray10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated. |
| steroid group | Active comparator | Drug: Mometasone nasal spraymometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being ages between 2 and 18
- undergoing elective surgery
- intubated patients over 1 hour
- ASA(American Society of Anesthesiologists) Class I-II patients
Key exclusion criteria (2 listed)
- Urgent surgeries
- Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
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 |
|---|---|---|
| Lidocaine 10% SprayAlso: lidocainelidocaine will be apply on the cuff | Drug | lidocaine group |
| Mometasone nasal sprayAlso: steroidmometasone spray will be applied on the cuff | Drug | steroid group |
Primary outcome
Visual analog scale (VAS) for pain
Time frame: 1 hour
Self Reported VAS at postoperative unit. VAS 0 is no pain VAS 10 is pain as bad as can be
Visual analog scale (VAS) for pain
Time frame: 6 hours
Self reported VAS postoperative at hour 6. VAS 0 is no pain VAS 10 is pain as bad as can be
Visual analog scale (VAS) for pain
Time frame: 12 hours
Self reported VAS postoperative at hour 12. VAS 0 is no pain VAS 10 is pain as bad as can be
Visual analog scale (VAS) for pain
Time frame: 24 hours
Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Ayse Z Turan study director
HEALTH AND SCİENCE UNIVERSITY DERINCE TRAINING AND RESEARCH HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 10% Spray and Mometasone nasal spray in people with Anesthesia Intubation Complication and Intubation Complication, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 18 Nov 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 Turkey (Türkiye). 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?
Visual analog scale (VAS) for pain (time frame: 1 hour). The study lists 4 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 18 Nov 2023.