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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

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.

Condition or disease Intervention/treatment Phase
Sore Throat Drug: xylocaine Drug: Dexamethasone Drug: Xylocaine and Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : November 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Xylocaine "X"
Patients received xylocaine gel as lubricant on endotracheal tube
Drug: xylocaine
First group were given xylocaine
Other Name: X

Experimental: Dexamethasone "D"
Patients were given dexamethasone 8 mg intravenously
Drug: Dexamethasone
Second group were given Dexamethasone
Other Name: D

Experimental: xylocaine and dexamethasone "XD"
Patients were given both xylocaine gel and dexamethasone 8 mg intravenously
Drug: Xylocaine and Dexamethasone
Third group were given both Xylocaine and Dexamethasone
Other Name: XD




Primary Outcome Measures :
  1. Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation. [ Time Frame: 4 months ]
    Questionnaire follow up in intubated patients.


Secondary Outcome Measures :
  1. Sore throat SCALE [ Time Frame: 4 months ]
    Sore throat scale from None,mild,moderate till severe.



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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682134


Sponsors and Collaborators
University of Jordan
Investigators
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Principal Investigator: Aboud Aljabari University of Jordan
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Responsible Party: Aboud Nayef AlJabari, Regional and Cardio-thoracic anesthesia doctor, University of Jordan
ClinicalTrials.gov Identifier: NCT02682134    
Other Study ID Numbers: AAlJabari
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Aboud Nayef AlJabari, University of Jordan:
Sore Throat
Intubation
Xylocaine
Dexamethasone
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Dexamethasone
Dexamethasone acetate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers