NCT02682134

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

February 5, 2016

Last Update Submit

February 10, 2016

Conditions

Sore Throat

Keywords

Sore ThroatIntubationXylocaineDexamethasone

Outcome Measures

Primary Outcomes (1)

  • Comparison in preventing sore throat: xylocaine gel versus dexamethasone or both following intubation.

    Questionnaire follow up in intubated patients.

    4 months

Secondary Outcomes (1)

  • Sore throat SCALE

    4 months

Study Arms (3)

Xylocaine "X"

EXPERIMENTAL

Patients received xylocaine gel as lubricant on endotracheal tube

Drug: xylocaine

Dexamethasone "D"

EXPERIMENTAL

Patients were given dexamethasone 8 mg intravenously

Drug: Dexamethasone

xylocaine and dexamethasone "XD"

EXPERIMENTAL

Patients were given both xylocaine gel and dexamethasone 8 mg intravenously

Drug: Xylocaine and Dexamethasone

Interventions

xylocaineDRUG

First group were given xylocaine

Also known as: X
Xylocaine "X"
DexamethasoneDRUG

Second group were given Dexamethasone

Also known as: D
Dexamethasone "D"
Xylocaine and DexamethasoneDRUG

Third group were given both Xylocaine and Dexamethasone

Also known as: XD
xylocaine and dexamethasone "XD"

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3.
  • Elective VS Emergency.
  • Cuffed endo-tracheal tubes.
  • Different types of surgery.

You may not qualify if:

  • Pregnant ladies.
  • ICU patients.
  • \<15 years of age
  • Laryngeal mask airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Interventions

LidocaineDexamethasoneFumigant 93

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Aboud Aljabari

    University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Regional and Cardio-thoracic anesthesia doctor

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 15, 2016

Study Start

November 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share