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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo (NaCl 0.9%)	NaCl 0.9%	-
Dexamethasone injection	Dexamethasone	Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Nausea and Vomiting	within 48 hours after surgery	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

Secondary Outcome Measures

Name	Time	Method
Degree of Post Operative Nausea and Vomiting	8 hours after surgery	mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Postoperative Pain After Physical Stress	4 and 8 hours after surgery	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)
Necessary Anesthesiological Medication	measured from beginning of anaesthesia to end of anaesthesia	Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group
Incidence of Postoperative Nausea and Vomiting	within 48 hours after surgery (PP)	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
Length of Hospital Stay	Difference between day of admission and day of discharge	Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group