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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ignazio Tarantino, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01189292
First received: July 19, 2010
Last updated: June 19, 2013
Last verified: June 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • postoperative nausea and vomiting [ Time Frame: Calculated area under the curve from nausea and vomiting score mesuared at 4,8,16,24,32,48 hours postoperatively (one single p value) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • postoperative pain [ Time Frame: Calculated area under the curve from nausea and vomiting score mesuared at 4,8,16,24,32,48 hours postoperatively (one single p value) ] [ Designated as safety issue: No ]
    Compare grade of pain after between the treatment (dexamethasone) and the control (saline) group

  • length of hospital stay [ Time Frame: Difference between day of admission and day of discharge ] [ Designated as safety issue: No ]
    Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group

  • wound healing [ Time Frame: 6-weeks follow-up ] [ Designated as safety issue: Yes ]
    Determine wound healing of both treatment arms in a 6-weeks follow-up

  • necessary anesthesiological medication [ Time Frame: measured from beginning of anaesthesia to end of anaesthesia ] [ Designated as safety issue: No ]
    Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group

  • Postoperative morbidity [ Time Frame: 6-weeks follow-up ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 19, 2010
Last Updated: June 19, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Nausea
Thyroid Diseases
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Endocrine System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014