A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff (LA-STEROID)
Primary Purpose
Anesthesia Intubation Complication, Intubation Complication, Sore Throat
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lidocaine 10% Spray
Mometasone nasal spray
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia Intubation Complication focused on measuring intubation, anesthesia, corticosteroids, lidocaine, complication of intubation
Eligibility Criteria
Inclusion Criteria:
- Being ages between 2 and 18
- undergoing elective surgery
- intubated patients over 1 hour
- ASA(American Society of Anesthesiologists) Class I-II patients
Exclusion Criteria:
- Urgent surgeries
- Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
Sites / Locations
- Health and Science University Derince Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
control group
lidocaine group
steroid group
Arm Description
In this group any drug will be applied on the cuff of the intubation tube
10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04085744
First Posted
September 7, 2019
Last Updated
November 13, 2019
Sponsor
Derince Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04085744
Brief Title
A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff
Acronym
LA-STEROID
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derince Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Intubation Complication, Intubation Complication, Sore Throat
Keywords
intubation, anesthesia, corticosteroids, lidocaine, complication of intubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
In this group any drug will be applied on the cuff of the intubation tube
Arm Title
lidocaine group
Arm Type
Active Comparator
Arm Description
10% lidocaine spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
Arm Title
steroid group
Arm Type
Active Comparator
Arm Description
mometasone furoate spray will be applied on the cuff of the intubation tube topically and patient will be intubated.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 10% Spray
Other Intervention Name(s)
lidocaine
Intervention Description
lidocaine will be apply on the cuff
Intervention Type
Drug
Intervention Name(s)
Mometasone nasal spray
Other Intervention Name(s)
steroid
Intervention Description
mometasone spray will be applied on the cuff
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) for pain
Description
Self Reported VAS at postoperative unit. VAS 0 is no pain VAS 10 is pain as bad as can be
Time Frame
1 hour
Title
Visual analog scale (VAS) for pain
Description
Self reported VAS postoperative at hour 6. VAS 0 is no pain VAS 10 is pain as bad as can be
Time Frame
6 hours
Title
Visual analog scale (VAS) for pain
Description
Self reported VAS postoperative at hour 12. VAS 0 is no pain VAS 10 is pain as bad as can be
Time Frame
12 hours
Title
Visual analog scale (VAS) for pain
Description
Self reported VAS at postoperative hour 24. VAS 0 is no pain VAS 10 is pain as bad as can be
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being ages between 2 and 18
undergoing elective surgery
intubated patients over 1 hour
ASA(American Society of Anesthesiologists) Class I-II patients
Exclusion Criteria:
Urgent surgeries
Tonsillectomies, adenoidectomies ..etc, operations that causes sore throat due to the operation area.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali U Olc, MD
Phone
+905555533211
Email
aliulvi90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayse Z Turan, MD
Phone
+905054695850
Email
ayse.zeynep@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Z Turan
Organizational Affiliation
HEALTH AND SCİENCE UNIVERSITY DERINCE TRAINING AND RESEARCH HOSPITAL
Official's Role
Study Director
Facility Information:
Facility Name
Health and Science University Derince Training and Research Hospital
City
Derince
State/Province
Kocaeli
ZIP/Postal Code
41900
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali U Olc, MD
First Name & Middle Initial & Last Name & Degree
Ayse Z Turan, MD
Phone
+905054695850
Email
ayse.zeynep@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison Of Local Anesthetic Agents And Steroid On Tracheal Tube Cuff
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