Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.

Official Title
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Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease.

Conditions
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Postoperative Pain, Postoperative Nausea and Vomit, Postoperative Vocal Function, Thyroidectomy

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: saline solution
* Procedure: Thyroidectomy, total or partial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patients undergoing thyroidectomy Exclusion Criteria: Patients who had received antiemetic therapy within 48 hours before surgery Patients with depression Chronic pain disorder Insulin-dependent diabetes mellitus History of severe and/or repeated PONV after previous minor surgery, that led to change from standard anesthetic protocol Pregnancy Age < 18 years Patients who had known malignant disease or had undergone previous thyroid or neck surgery

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A (dexamethasone)<br>20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered | Drug: Dexamethasone<br>* 20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered<br>Procedure: Thyroidectomy, total or partial<br>* Surgical standard intervention<br>|
| Placebo Comparator: B (Control)<br>20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous | Drug: saline solution<br>* 20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous<br>Procedure: Thyroidectomy, total or partial<br>* Surgical standard intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomit (PONV) measured in 4 grades |  | 8, 24, 32 and 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale |  | 8, 24, 32 and 48 hours after surgery | 
| Vocal function measured in a 0-100 Visual analog scale |  | 8, 24, 32 and 48 hours after surgery |