Trial record 19 of 204 for:
Open Studies | "Thyroid Diseases"
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery (tPONV)
This study is currently recruiting participants.
Verified May 2013 by Cantonal Hospital of St. Gallen
Sponsor:
Cantonal Hospital of St. Gallen
Collaborator:
Clinical trial unit (CTU) of the Cantonal Hospital St.Gallen (additional funding)
Information provided by (Responsible Party):
Ignazio Tarantino, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01189292
First received: July 19, 2010
Last updated: May 6, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thyroidectomy Thyroid Diseases |
Drug: Dexamethasone Other: NaCl 0.9% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Thyroid
U.S. FDA Resources
Further study details as provided by Cantonal Hospital of St. Gallen:
Primary Outcome Measures:
- postoperative nausea and vomiting [ Time Frame: Calculated area under the curve from nausea and vomiting score mesuared at 4,8,16,24,32,48 hours postoperatively (one single p value) ] [ 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)
Secondary Outcome Measures:
- postoperative pain [ Time Frame: Calculated area under the curve from nausea and vomiting score mesuared at 4,8,16,24,32,48 hours postoperatively (one single p value) ] [ Designated as safety issue: No ]Compare grade of pain after between the treatment (dexamethasone) and the control (saline) group
- 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
- wound healing [ Time Frame: 6-weeks follow-up ] [ Designated as safety issue: Yes ]Determine wound healing of both treatment arms in a 6-weeks follow-up
- 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
- Postoperative morbidity [ Time Frame: 6-weeks follow-up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 152 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dexamethasone injection
Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)
|
Drug: Dexamethasone
8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
Other Name: Mephameson
|
| Placebo Comparator: Placebo (NaCl 0.9%) |
Other: NaCl 0.9%
2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189292
Contacts
| Contact: Ignazio Tarantino, MD, MSc | +41714942939 | ignazio.tarantino@kssg.ch |
Locations
| Switzerland | |
| Department of Surgery | Recruiting |
| St. Gallen, Switzerland, 9007 | |
| Contact: Ignazio Tarantino, MD, MSc +41714942939 ignazio.tarantino@kssg.ch | |
| Principal Investigator: Thomas Clerici, MD | |
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Clinical trial unit (CTU) of the Cantonal Hospital St.Gallen (additional funding)
Investigators
| Principal Investigator: | Thomas Clerici, MD | Cantonal Hospital St. Gallen |
More Information
No publications provided
| Responsible Party: | Ignazio Tarantino, M.D:, Cantonal Hospital of St. Gallen |
| ClinicalTrials.gov Identifier: | NCT01189292 History of Changes |
| Other Study ID Numbers: | EKSG 10/082/2B |
| Study First Received: | July 19, 2010 |
| Last Updated: | May 6, 2013 |
| Health Authority: | 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 Signs and Symptoms, Digestive Signs and Symptoms Endocrine System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents 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 May 21, 2013