Sore Throat Prevention Following Intubation
Primary Purpose
Sore Throat
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
xylocaine
Dexamethasone
Xylocaine and Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat focused on measuring Sore Throat, Intubation, Xylocaine, Dexamethasone
Eligibility Criteria
Inclusion Criteria:
- ASA 1-3.
- Elective VS Emergency.
- Cuffed endo-tracheal tubes.
- Different types of surgery.
Exclusion Criteria:
- Pregnant ladies.
- ICU patients.
- <15 years of age
- Laryngeal mask airway
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Xylocaine "X"
Dexamethasone "D"
xylocaine and dexamethasone "XD"
Arm Description
Patients received xylocaine gel as lubricant on endotracheal tube
Patients were given dexamethasone 8 mg intravenously
Patients were given both xylocaine gel and dexamethasone 8 mg intravenously
Outcomes
Primary Outcome Measures
Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.
Questionnaire follow up in intubated patients.
Secondary Outcome Measures
Sore throat SCALE
Sore throat scale from None,mild,moderate till severe.
Full Information
NCT ID
NCT02682134
First Posted
February 5, 2016
Last Updated
February 10, 2016
Sponsor
University of Jordan
1. Study Identification
Unique Protocol Identification Number
NCT02682134
Brief Title
Sore Throat Prevention Following Intubation
Official Title
Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.
Detailed Description
Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone).
The investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
Sore Throat, Intubation, Xylocaine, Dexamethasone
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xylocaine "X"
Arm Type
Experimental
Arm Description
Patients received xylocaine gel as lubricant on endotracheal tube
Arm Title
Dexamethasone "D"
Arm Type
Experimental
Arm Description
Patients were given dexamethasone 8 mg intravenously
Arm Title
xylocaine and dexamethasone "XD"
Arm Type
Experimental
Arm Description
Patients were given both xylocaine gel and dexamethasone 8 mg intravenously
Intervention Type
Drug
Intervention Name(s)
xylocaine
Other Intervention Name(s)
X
Intervention Description
First group were given xylocaine
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
D
Intervention Description
Second group were given Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Xylocaine and Dexamethasone
Other Intervention Name(s)
XD
Intervention Description
Third group were given both Xylocaine and Dexamethasone
Primary Outcome Measure Information:
Title
Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.
Description
Questionnaire follow up in intubated patients.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Sore throat SCALE
Description
Sore throat scale from None,mild,moderate till severe.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1-3.
Elective VS Emergency.
Cuffed endo-tracheal tubes.
Different types of surgery.
Exclusion Criteria:
Pregnant ladies.
ICU patients.
<15 years of age
Laryngeal mask airway
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aboud Aljabari
Organizational Affiliation
University of Jordan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sore Throat Prevention Following Intubation
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