ThyroidectomyPhase 3tPONVNCT01189292
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
A Phase 3 study testing Dexamethasone and NaCl 0.9% in people with Thyroidectomy and Thyroid Diseases, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Thyroid Diseases
- What is being tested?
- Dexamethasone and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Planned partial or total thyroidectomy
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Thyroidectomy, Thyroid Diseases
- Being tested
- Dexamethasone, NaCl 0.9%
- Keywords
- postoperative nausea and vomitus, PONV, thyroid surgery
- Medical subject headings
- Thyroid Diseases, Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Mephameson
8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
NaCl 0.9%Other
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone injection | Active comparator | Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) Receives: Drug: Dexamethasone |
| Placebo (NaCl 0.9%) | Placebo comparator | Not described Receives: Other: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 48 hours after surgery
Secondary outcomes (6)
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
Measured: within 48 hours after surgery (PP)
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
Measured: 4 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
Measured: 8 hours after surgery
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)
Measured: 4 and 8 hours after surgery
Length of Hospital Stay
Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group
Measured: Difference between day of admission and day of discharge
Necessary Anesthesiological Medication
Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group
Measured: measured from beginning of anaesthesia to end of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignazio Tarantino, Cantonal Hospital of St. Gallen
- Investigators
- Thomas Clerici, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189292
- Sponsor's protocol ID
- EKSG 10/082/2B
- Acronym
- tPONV
- Status last verified
- Jun 2015
- First submitted
- 19 Jul 2010
- Last updated
- 7 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25563879Tarantino 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.
PubMed 24015953
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
- ClinicalTrials.gov ID
- NCT01189292
- Acronym / sponsor ID
- tPONV / EKSG 10/082/2B
- Conditions
- Thyroidectomy, Thyroid Diseases
- Keywords
- postoperative nausea and vomitus, PONV, thyroid surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 7 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone injection | Active comparator | Drug: DexamethasoneAdministration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) |
| Placebo (NaCl 0.9%) | Placebo comparator | Other: NaCl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Planned partial or total thyroidectomy
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Mephameson8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery | Drug | Dexamethasone injection |
| NaCl 0.9%2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery | Other | Placebo (NaCl 0.9%) |
Primary outcome
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
6 secondary outcomes
Incidence of Postoperative Nausea and Vomiting
Time frame: within 48 hours after surgery (PP)
Degree of Post Operative Nausea and Vomiting
Time frame: 4 hours after surgery
Degree of Post Operative Nausea and Vomiting
Time frame: 8 hours after surgery
Postoperative Pain After Physical Stress
Time frame: 4 and 8 hours after surgery
Length of Hospital Stay
Time frame: Difference between day of admission and day of discharge
Necessary Anesthesiological Medication
Time frame: measured from beginning of anaesthesia to end of anaesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25563879Tarantino 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.
- Derived from this study: PubMed 24015953Tarantino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Clerici, MD principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and NaCl 0.9% in people with Thyroidectomy and Thyroid Diseases, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Nausea and Vomiting (time frame: within 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.