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

Thyroid Diseases Clinical Trial

— tPONV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189292
• Other study ID #: EKSG 10/082/2B
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2010
• Last updated: June 29, 2015
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2015
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroidectomy

Intervention

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

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

Locations

Country	Name	City	State
Switzerland	Department of Surgery	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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 (PP)	No
Secondary	Degree of Post Operative Nausea and Vomiting	mild nausea:......single administration of an antiemetic drug; severe nausea: repeated administration of antiemetic drugs; vomiting:...........at least one vomiting event	4 hours after surgery	No
Secondary	Degree of Post Operative Nausea and Vomiting	mild nausea:......single administration of an antiemetic drug; severe nausea: repeated administration of antiemetic drugs; vomiting:...........at least one vomiting event	8 hours after surgery	No
Secondary	Postoperative Pain After Physical Stress	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)	4 and 8 hours after surgery	No
Secondary	Length of Hospital Stay	Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group	Difference between day of admission and day of discharge	No
Secondary	Necessary Anesthesiological Medication	Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group	measured from beginning of anaesthesia to end of anaesthesia	No