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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sore Throat, Cough

Intervention / Treatment
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* Drug: betamethasone gel
* Drug: lidocaine jelly
* Drug: distilled water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: betamethasone gel<br>betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. | Drug: betamethasone gel<br>* betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.<br>Drug: distilled water<br>* The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.<br>|
| Experimental: lidocaine jelly<br>lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. | Drug: lidocaine jelly<br>* the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.<br>Drug: distilled water<br>* The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.<br>|
| Placebo Comparator: distilled water<br>betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 hours after surgery | 
| 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). | 1 hour after surgery | 
| 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). | 1 hour after surgery | 
| 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). | 1 hour after surgery | 
| 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). | 6 hours after surgery | 
| 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). | 6 hours after surgery | 
| 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). | 24 hours after surgery | 
| 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). | 6 hours after surgery | 
| 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). | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Betamethasone gel, lidocaine jelly, sore throat, cough, hoarseness of voice, Syndrome incidence after intubation