Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
NCT ID: NCT01189292
Last Updated: 2015-07-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
152 participants
INTERVENTIONAL
2011-01-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Steroid Before Thyroidectomy
NCT00619086
Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function
NCT00888303
Dexamethasone and Wound Healing After Thyroid Surgery
NCT02304250
The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery
NCT01045876
Nausea and Pain Prophylaxis During Thyroid Surgery
NCT00569920
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexamethasone injection
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
Dexamethasone
8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
Placebo (NaCl 0.9%)
NaCl 0.9%
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone
8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
NaCl 0.9%
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Planned partial or total thyroidectomy
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cantonal Hospital of St. Gallen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ignazio Tarantino
M.D:
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Clerici, MD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital St. Gallen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Surgery
Sankt Gallen, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EKSG 10/082/2B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.