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Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of

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ClinicalTrials.gov Identifier: NCT02114021
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Islamic Azad University, Tehran
Information provided by (Responsible Party):
Fatemeh Shahbazi, Tehran University of Medical Sciences

Study Description
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Brief Summary:

ABSTRACT:

The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.

99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.

For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.


Condition or disease Intervention/treatment Phase
Sore Throat Cough Drug: betamethasone gel Drug: lidocaine jelly Drug: distilled water Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough Sore Throat

Arms and Interventions
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Arm Intervention/treatment
Experimental: betamethasone gel
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
 Drug: betamethasone gel
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Drug: distilled water
The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Experimental: lidocaine jelly
lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
 Drug: lidocaine jelly
the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Drug: distilled water
The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Placebo Comparator: distilled water
betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.


Outcome Measures
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Primary Outcome Measures :
  1. sore throat [ Time Frame: 24 hours after surgery ]
    For the all the patients, the incidence of postoperative cough in 24 hours follow-up based on the different types of medications were obtained (using questionnaire).

  2. cough [ Time Frame: 1 hour after surgery ]
    For the all the patients, the incidence of postoperative cough in 1 hour follow-up periods based on the different types of medications were obtained (using questionnaire).

  3. hoarseness of voice [ Time Frame: 1 hour after surgery ]
    For the all patients, the incidence of postoperative hoarseness of the voice in 1 hour follow-up period based on the different types of medications were obtained (using questionnaire).

  4. sore throat [ Time Frame: 1 hour after surgery ]
    For the all the patients, the incidence of postoperative cough in 1 hour follow up based on the different types of medications were obtained (using questionnaire).

  5. sore throat [ Time Frame: 6 hours after surgery ]
    For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).

  6. cough [ Time Frame: 6 hours after surgery ]
    For the all the patients, the incidence of postoperative cough in 6 hours follow-up periods based on the different types of medications were obtained (using questionnaire).

  7. cough [ Time Frame: 24 hours after surgery ]
    For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).

  8. hoarseness of voice [ Time Frame: 6 hours after surgery ]
    For the all patients, the incidence of postoperative hoarseness of the voice in 6 hours follow-up period based on the different types of medications were obtained (using questionnaire).

  9. hoarseness of voice [ Time Frame: 24 hours after surgery ]
    For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 years<age>15 years
  2. no acute upper respiratory infections and no sore throat
  3. candidate for elective surgery unrelated to the throat
  4. The lack of airways difficulties
  5. candidate for general anesthesia with intubation
  6. no contraindications for receiving steroid
  7. surgery time < 240 minutes
  8. intubation up to 2 times
  9. tracheal tube cuff pressure = 25-30 cm H2o
  10. fasting for 8-6 hours prior to surgery
  11. ASA I and ASAII and
  12. Surgery under general anesthesia and endotracheal intubation

Exclusion Criteria:

  1. use of nasogastric tube or throat packs
  2. patients with upper respiratory tract infection
  3. patients on steroid therapy were excluded from the study
Contacts and Locations
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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): NCT02114021


Locations
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Iran, Islamic Republic of
Department of Anesthesiology, Booali Hospital, Islamic Azad University,
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Islamic Azad University, Tehran
More Information
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Layout table for additonal information
Responsible Party: Fatemeh Shahbazi, Principal Investigator, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02114021    
Other Study ID Numbers: 08/13/1019
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Keywords provided by Fatemeh Shahbazi, Tehran University of Medical Sciences:
Syndrome incidence after intubation
Betamethasone gel
lidocaine jelly
 sore throat
cough
hoarseness of voice
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Cough
Hoarseness
Dysphonia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Voice Disorders
Laryngeal Diseases
Neurologic Manifestations
 Nervous System Diseases
Betamethasone
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents