Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery

Study Overview
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Brief Summary
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The study is to compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy.

Official Title
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Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery

Conditions
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Thyroidectomy, Thyroid Diseases

Intervention / Treatment
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* Drug: Dexamethasone
* Other: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Planned partial or total thyroidectomy Exclusion Criteria: History of adverse effects to dexamethasone or propyleneglycol or di-natrium-EDTA Patients with chronic pain Necessity for opioids-application in the postoperative course Not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml) Patients with Diabetes mellitus Pregnancy (test in young women) Glaucoma Patients who received antiemetic therapy within 48h before surgery Patients with acute pain requiring painkillers others than paracetamol or more than single dose NSAR treatment within 48h before surgery Use of psychotropic drugs Incompliant patients Preoperatively high suspicion of malignancy Re-operations

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone injection<br>Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) | Drug: Dexamethasone<br>* 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery<br>* Other names: Mephameson;|
| Placebo Comparator: Placebo (NaCl 0.9%)<br> | Other: NaCl 0.9%<br>* 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Nausea and Vomiting | Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point) any PONV event within 48 hours after surgery PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery | within 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Nausea and Vomiting | Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point) any PONV event within 48 hours after surgery PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery | within 48 hours after surgery (PP) | 
| Degree of Post Operative Nausea and Vomiting | mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event | 4 hours after surgery | 
| Degree of Post Operative Nausea and Vomiting | mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event | 8 hours after surgery | 
| Postoperative Pain After Physical Stress | Compare grade of pain between the treatment (dexamethasone) and the control (saline) group Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1 before obtaining the pain rating, patients were asked to turn their heads (physical stress) | 4 and 8 hours after surgery | 
| Length of Hospital Stay | Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group | Difference between day of admission and day of discharge | 
| Necessary Anesthesiological Medication | Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group | measured from beginning of anaesthesia to end of anaesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative nausea and vomitus, PONV, thyroid surgery