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

Primary Purpose

Thyroidectomy, Thyroid Diseases

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Dexamethasone
NaCl 0.9%
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroidectomy focused on measuring postoperative nausea and vomitus, PONV, thyroid surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone injection

Placebo (NaCl 0.9%)

Arm Description

Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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)
Length of Hospital Stay
Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group
Necessary Anesthesiological Medication
Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group

Full Information

First Posted
July 19, 2010
Last Updated
June 29, 2015
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT01189292
Brief Title
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Acronym
tPONV
Official Title
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy, Thyroid Diseases
Keywords
postoperative nausea and vomitus, PONV, thyroid surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone injection
Arm Type
Active Comparator
Arm Description
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Arm Title
Placebo (NaCl 0.9%)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Mephameson
Intervention Description
8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
Intervention Type
Other
Intervention Name(s)
NaCl 0.9%
Intervention Description
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
Primary Outcome Measure Information:
Title
Incidence of Postoperative Nausea and Vomiting
Description
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
Time Frame
within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Incidence of Postoperative Nausea and Vomiting
Description
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
Time Frame
within 48 hours after surgery (PP)
Title
Degree of Post Operative Nausea and Vomiting
Description
mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Time Frame
4 hours after surgery
Title
Degree of Post Operative Nausea and Vomiting
Description
mild nausea:......single administration of an antiemetic drug severe nausea: repeated administration of antiemetic drugs vomiting:...........at least one vomiting event
Time Frame
8 hours after surgery
Title
Postoperative Pain After Physical Stress
Description
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)
Time Frame
4 and 8 hours after surgery
Title
Length of Hospital Stay
Description
Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group
Time Frame
Difference between day of admission and day of discharge
Title
Necessary Anesthesiological Medication
Description
Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group
Time Frame
measured from beginning of anaesthesia to end of anaesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Clerici, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25563879
Citation
Tarantino I, Warschkow R, Beutner U, Kolb W, Luthi A, Luthi C, Schmied BM, Clerici T. Efficacy of a Single Preoperative Dexamethasone Dose to Prevent Nausea and Vomiting After Thyroidectomy (the tPONV Study): A Randomized, Double-blind, Placebo-controlled Clinical Trial. Ann Surg. 2015 Dec;262(6):934-40. doi: 10.1097/SLA.0000000000001112.
Results Reference
derived
PubMed Identifier
24015953
Citation
Tarantino I, Beutner U, Kolb W, Muller SA, Luthi C, Luthi A, Schmied BM, Clerici T, Warschkow R. Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study. BMC Anesthesiol. 2013 Sep 9;13(1):19. doi: 10.1186/1471-2253-13-19.
Results Reference
derived

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

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