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

Cantonal Hospital of St. Gallen

Status and phase: Completed; Phase 3

Conditions: Thyroid Diseases; Thyroidectomy

Treatments: Drug: Dexamethasone; Other: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01189292

EKSG 10/082/2B

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

Dexamethasone injection

Active Comparator group

Description:

Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)

Treatment:

Drug: Dexamethasone

Placebo (NaCl 0.9%)

Placebo Comparator group

Treatment:

Other: NaCl 0.9%