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

Primary Purpose

Sore Throat, Cough

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
betamethasone gel
lidocaine jelly
distilled water
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat focused on measuring Syndrome incidence after intubation, Betamethasone gel, lidocaine jelly, sore throat, cough, hoarseness of voice

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, Booali Hospital, Islamic Azad University,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

betamethasone gel

lidocaine jelly

distilled water

Arm Description

betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.

Outcomes

Primary Outcome Measures

sore throat
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).
cough
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).
hoarseness of voice
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).
sore throat
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).
sore throat
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).
cough
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).
cough
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).
hoarseness of voice
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).
hoarseness of voice
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).

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
April 14, 2014
Sponsor
Tehran University of Medical Sciences
Collaborators
Islamic Azad University, Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT02114021
Brief Title
Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Islamic Azad University, Tehran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat, Cough
Keywords
Syndrome incidence after intubation, Betamethasone gel, lidocaine jelly, sore throat, cough, hoarseness of voice

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
betamethasone gel
Arm Type
Experimental
Arm Description
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Arm Title
lidocaine jelly
Arm Type
Experimental
Arm Description
lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Arm Title
distilled water
Arm Type
Placebo Comparator
Arm Description
betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Intervention Type
Drug
Intervention Name(s)
betamethasone gel
Intervention Description
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Intervention Type
Drug
Intervention Name(s)
lidocaine jelly
Intervention Description
the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Intervention Type
Drug
Intervention Name(s)
distilled water
Intervention Description
The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
Primary Outcome Measure Information:
Title
sore throat
Description
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).
Time Frame
24 hours after surgery
Title
cough
Description
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).
Time Frame
1 hour after surgery
Title
hoarseness of voice
Description
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).
Time Frame
1 hour after surgery
Title
sore throat
Description
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).
Time Frame
1 hour after surgery
Title
sore throat
Description
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).
Time Frame
6 hours after surgery
Title
cough
Description
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).
Time Frame
6 hours after surgery
Title
cough
Description
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).
Time Frame
24 hours after surgery
Title
hoarseness of voice
Description
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).
Time Frame
6 hours after surgery
Title
hoarseness of voice
Description
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).
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 years<age>15 years no acute upper respiratory infections and no sore throat candidate for elective surgery unrelated to the throat The lack of airways difficulties candidate for general anesthesia with intubation no contraindications for receiving steroid surgery time < 240 minutes intubation up to 2 times tracheal tube cuff pressure = 25-30 cm H2o fasting for 8-6 hours prior to surgery ASA I and ASAII and Surgery under general anesthesia and endotracheal intubation Exclusion Criteria: use of nasogastric tube or throat packs patients with upper respiratory tract infection patients on steroid therapy were excluded from the study
Facility Information:
Facility Name
Department of Anesthesiology, Booali Hospital, Islamic Azad University,
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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