Phase 3
N=152
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Thyroidectomy · Thyroid Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01189292 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Incidence of Postoperative Nausea and Vomiting — 29; 57 percentage of participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); NaCl 0.9% (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cantonal Hospital of St. Gallen
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Postoperative Nausea and Vomiting |
28; 52 | 0.006 sig |
| SECONDARY Incidence of Postoperative Nausea and Vomiting |
28; 52 | 0.006 sig |
| SECONDARY Degree of Post Operative Nausea and Vomiting |
5; 7; 0; 3; 8; 12 | — |
| SECONDARY Degree of Post Operative Nausea and Vomiting |
5; 7; 0; 3; 8; 12 | — |
| SECONDARY Postoperative Pain After Physical Stress |
1.88; 2.09; 1.88; 2.01 | 0.674 |
| SECONDARY Length of Hospital Stay |
48.3; 48.1 | 0.835 |
| SECONDARY Necessary Anesthesiological Medication |
1097; 1168; 1.944; 1.978; 0.427; 0.444 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01189292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.