Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

Study Overview
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Brief Summary
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The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Detailed Description
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The postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. Dexamethasone is known to effective for the prevention of postoperative sore throat. The combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated. The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Official Title
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Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for urologic surgery under general anesthesia ASA I-III Exclusion Criteria: Patients with recent sore throat Patients with neck surgery Patients with anticipated difficult airway Patients with Mallampati grade 3 Patients with severe cardiovascular or pulmonary disease Patients with allergic history to dexamethasone or paracetamol Patients with liver function disorder Patients with liver disease

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Dexamethasone will be administered 30 minutes before the anesthetic induction. | Drug: Dexamethasone<br>* Dexamethasone will be administered.<br>|
| Experimental: Dexamethasone+ Paracetamol (DP)<br>Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery. | Drug: Dexamethasone<br>* Dexamethasone will be administered.<br>Drug: Paracetamol<br>* Paracetamol will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sore throat | Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe) | 1 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative sore throat degree | Postoperative sore throat degree after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable). | 0, 1, 6, 24 hour postoperatively | 
| Postoperative pain | Postoperative pain after 0, 1, 6, 24 hour postoperatively will be measured (11 points, 0:none, 10:worst imaginable). | 0, 1, 6, 24 hour postoperatively | 
| Nausea | Nausea will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Vomiting | Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Somnolence | Somnolence will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Shivering | Shivering will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Headache | Headache will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Hoarseness | Hoarseness will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Dysphagia | Dysphagia will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Analgesics | Analgesics usage will be measured at 0, 1, 6 and 24 hour postoperatively. | 0, 1, 6, 24 hour postoperatively | 
| Postoperative sore throat | Postoperative sore throat after 0, 6, 24 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe) | 0, 6, 24 hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Period, Anesthesia, General, Intubation, Intratracheal, Dexamethasone, Acetaminophen