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

NCT01189292 | Completed Phase 3 Results

• 1 other identifier: EKSG 10/082/2B
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroidectomy; Thyroid Diseases

Keywords

postoperative nausea and vomitus; PONV; thyroid surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of Postoperative Nausea and Vomiting

  within 48 hours after surgery (PP)

• Degree of Post Operative Nausea and Vomiting

  4 hours after surgery

• Degree of Post Operative Nausea and Vomiting

  8 hours after surgery

• Postoperative Pain After Physical Stress

  4 and 8 hours after surgery

• Length of Hospital Stay

  Difference between day of admission and day of discharge

Study Arms (2)

Dexamethasone injection

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Placebo (NaCl 0.9%)

PLACEBO COMPARATOR

Other: NaCl 0.9%

Interventions

Dexamethasone DRUG

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

Also known as: Mephameson

Dexamethasone injection

NaCl 0.9% OTHER

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

Placebo (NaCl 0.9%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Planned partial or total thyroidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Department of Surgery

Sankt Gallen, 9007, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 25563879 DERIVED

• 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.

  PMID: 24015953 DERIVED

MeSH Terms

Conditions

Thyroid Diseases; Postoperative Nausea and Vomiting; Vomiting

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

all patients received a bilateral superficial cervical plexus block during surgery which could explain the very low postoperative pain scores compared to other similar studies

Results Point of Contact

• Title: Dr. Ignazio Tarantino
• Organization: Department of General, Abdominal and Transplant Surgery, University of Heidelberg

ignazio.tarantino@med.uni-heidelberg.de

Study Officials

• Thomas Clerici, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D:

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: August 26, 2010
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 7, 2015
• Results First Posted: July 7, 2015

Record last verified: 2015-06

Locations

CH (1)