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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189292
First Posted: August 26, 2010
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ignazio Tarantino, Cantonal Hospital of St. Gallen
  Purpose
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.

Condition Intervention Phase
Thyroidectomy Thyroid Diseases Drug: Dexamethasone Other: NaCl 0.9% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery

Resource links provided by NLM:


Further study details as provided by Ignazio Tarantino, Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Incidence of Postoperative Nausea and Vomiting [ Time Frame: within 48 hours after surgery ]

    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


Secondary Outcome Measures:
  • Incidence of Postoperative Nausea and Vomiting [ Time Frame: within 48 hours after surgery (PP) ]

    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

  • Degree of Post Operative Nausea and Vomiting [ Time Frame: 4 hours after surgery ]

    mild nausea:......single administration of an antiemetic drug

    severe nausea: repeated administration of antiemetic drugs

    vomiting:...........at least one vomiting event


  • Degree of Post Operative Nausea and Vomiting [ Time Frame: 8 hours after surgery ]

    mild nausea:......single administration of an antiemetic drug

    severe nausea: repeated administration of antiemetic drugs

    vomiting:...........at least one vomiting event


  • Postoperative Pain After Physical Stress [ Time Frame: 4 and 8 hours after surgery ]

    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)

  • Length of Hospital Stay [ Time Frame: Difference between day of admission and day of discharge ]
    Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group

  • Necessary Anesthesiological Medication [ Time Frame: measured from beginning of anaesthesia to end of anaesthesia ]
    Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group


Enrollment: 152
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mephameson
Placebo Comparator: Placebo (NaCl 0.9%) Other: NaCl 0.9%
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189292


Locations
Switzerland
Department of Surgery
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Thomas Clerici, MD Cantonal Hospital St. Gallen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ignazio Tarantino, M.D:, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01189292     History of Changes
Other Study ID Numbers: EKSG 10/082/2B
First Submitted: July 19, 2010
First Posted: August 26, 2010
Results First Submitted: February 26, 2015
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015
Last Verified: June 2015

Keywords provided by Ignazio Tarantino, Cantonal Hospital of St. Gallen:
postoperative nausea and vomitus
PONV
thyroid surgery

Additional relevant MeSH terms:
Thyroid Diseases
Nausea
Vomiting
Endocrine System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action