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

Cantonal Hospital of St. Gallen152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

152

Conditions

Thyroidectomy Thyroid Diseases

Interventions

DexamethasoneDRUG

8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery

NaCl 0.9%OTHER

2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Surgery

Sankt Gallen, Switzerland

Outcomes

Primary Outcomes

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

Time frame: within 48 hours after surgery

Secondary Outcomes

Incidence of Postoperative Nausea and Vomiting

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 4 and 8 hours after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.