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Sore Throat Prevention Following Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682134
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Aboud Nayef AlJabari, University of Jordan

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 15, 2016
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation. [ Time Frame: 4 months ]
Questionnaire follow up in intubated patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
Sore throat SCALE [ Time Frame: 4 months ]
Sore throat scale from None,mild,moderate till severe.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sore Throat Prevention Following Intubation
Official Title  ICMJE Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Sore Throat
Intervention  ICMJE
  • Drug: xylocaine
    First group were given xylocaine
    Other Name: X
  • Drug: Dexamethasone
    Second group were given Dexamethasone
    Other Name: D
  • Drug: Xylocaine and Dexamethasone
    Third group were given both Xylocaine and Dexamethasone
    Other Name: XD
Study Arms  ICMJE
  • Experimental: Xylocaine "X"
    Patients received xylocaine gel as lubricant on endotracheal tube
    Intervention: Drug: xylocaine
  • Experimental: Dexamethasone "D"
    Patients were given dexamethasone 8 mg intravenously
    Intervention: Drug: Dexamethasone
  • Experimental: xylocaine and dexamethasone "XD"
    Patients were given both xylocaine gel and dexamethasone 8 mg intravenously
    Intervention: Drug: Xylocaine and Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2016)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682134
Other Study ID Numbers  ICMJE AAlJabari
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Aboud Nayef AlJabari, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aboud Aljabari University of Jordan
PRS Account University of Jordan
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP