Benzydamine HCl for Postoperative Sore Throat

Study Overview
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Brief Summary
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To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.

Detailed Description
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The investigators will assign patients into either the benzydamine hydrochloride or the control group. The whole ETT cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.

Official Title
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Efficacy of Benzydamine Hydrochloride Dripping at Endotracheal Tube Cuff for Prevention of Postoperative Sore Throat

Conditions
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For Intervention

Intervention / Treatment
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* Drug: benzydamine HCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-65 years ASA status I-II Mallampati grade I-II Duration of surgery less than 4 hours Patients placed in the supine position Exclusion Criteria: Undergoing oral, cervical spine or thyroid surgery More than one attempt of ETT intubation or intubated with a technique of rapid sequence induction with cricoid pressure Insertion of nasogastric/orogastric tube or esophageal stethoscope Complaint of sore throat or hoarseness Presence of upper respiratory tract infection within 7 days prior to the operation Gastroesophageal reflux Known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (NSAIDs)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: nothing<br>nothing will be dripped on the cuff of the endotracheal tube in the control group | |
| Experimental: benzydamine HCl<br>benzydamine HCl will be dripped on the cuff of the endotracheal tube 5 minutes before induction of general anesthesia | Drug: benzydamine HCl<br>* 3 ml (4.5 mg) of benzydamine hydrochloride will be dripped on the cuff of the endotracheal tube 5 minutes prior to induction of general anesthesia<br>* Other names: Difflam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic effect | evaluate pain score for sore throat at 0, 2, 4, 6, 12 and 24 hours after the operation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects of benzydamine hydrochloride | the incidence of throat numbness, throat burning sensation, dry mouth and thirst)within 24 hours after the operation | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benzydamine HCl, endotracheal tube, postoperative sore throat