Clinical trial NCT01189292: Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Official title: Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroidectomy
Thyroid Diseases
Keywords: postoperative nausea and vomitus
PONV
thyroid surgery
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting
timeFrame: within 48 hours after surgery (PP)
measure: Degree of Post Operative Nausea and Vomiting
timeFrame: 4 hours after surgery
measure: Degree of Post Operative Nausea and Vomiting
timeFrame: 8 hours after surgery
measure: Postoperative Pain After Physical Stress
timeFrame: 4 and 8 hours after surgery
measure: Length of Hospital Stay
timeFrame: Difference between day of admission and day of discharge
measure: Necessary Anesthesiological Medication
timeFrame: measured from beginning of anaesthesia to end of anaesthesia
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Thomas Clerici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tarantino I, Warschkow R, Beutner U, Kolb W, Luthi A, Luthi C, Schmied BM, Clerici T. Efficacy of a Single Preoperative Dexamethasone Dose to Prevent Nausea and Vomiting After Thyroidectomy (the tPONV Study): A Randomized, Double-blind, Placebo-controlled Clinical Trial. Ann Surg. 2015 Dec;262(6):934-40. doi: 10.1097/SLA.0000000000001112.
citation: Tarantino I, Beutner U, Kolb W, Muller SA, Luthi C, Luthi A, Schmied BM, Clerici T, Warschkow R. Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study. BMC Anesthesiol. 2013 Sep 9;13(1):19. doi: 10.1186/1471-2253-13-19.