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Completed

NCT Number: NCT01189292

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

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.

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Key information

Conditions

Thyroidectomy Endocrine System Diseases Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Thyroid Diseases Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Surgery

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Other names: Mephameson

NaCl 0.9%

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Acronym: tPONV

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 26, 2010
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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