Preoperative Single-Dose Steroid Application For The Treatment Of Nausea And Vomiting After Thyroid


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

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

Primary Outcome Measures:

Incidence of Postoperative Nausea and Vomiting [ Time Frame: within 48 hours after surgery ] [ 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)

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) ] [ 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)

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group

Age > 18

Planned partial or total thyroidectomy

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

Department of Surgery

St. Gallen, Switzerland, 9007

Sponsors and Collaborators

Cantonal Hospital of St. Gallen

Thomas Clerici, MD

Cantonal Hospital St. Gallen

Publications automatically indexed to this study by ClinicalTrials. gov Identifier (NCT Number):

Ignazio Tarantino, M. D. Cantonal Hospital of St. Gallen

Other Study ID Numbers:

Study First Received:

Results First Received:

February 26, 2015

Switzerland: Ethikkommission Switzerland: Swissmedic

Keywords provided by 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 Dexamethasone 21-phosphate 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

ClinicalTrials. gov processed this record on September 19, 2016