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

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 Overview

• Status: Completed
• Conditions: Thyroid Diseases; Thyroidectomy
• Intervention / Treatment: Drug: Dexamethasone; Other: NaCl 0.9%

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9007
    • Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone injection; Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)	Drug: Dexamethasone; 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery; Other Names: Mephameson
Placebo Comparator: Placebo (NaCl 0.9%)	Other: NaCl 0.9%; 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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)	4 and 8 hours after surgery
Length of Hospital Stay	Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group	Difference between day of admission and day of discharge
Necessary Anesthesiological Medication	Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group	measured from beginning of anaesthesia to end of anaesthesia

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Thomas Clerici, MD, Cantonal Hospital St. Gallen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: PONV; thyroid surgery; postoperative nausea and vomitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Signs and Symptoms, Digestive; Nausea; Vomiting; Thyroid Diseases; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: EKSG 10/082/2B