Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (dexamethasone) | Active Comparator | 20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered |
|
| B (Control) | Placebo Comparator | 20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nausea and vomit (PONV) measured in 4 grades | 8, 24, 32 and 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale | 8, 24, 32 and 48 hours after surgery | |
| Vocal function measured in a 0-100 Visual analog scale | 8, 24, 32 and 48 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Feroci, MD | Contact | +393398382381 | fferoci@yahoo.it | |
| Marco Scatizzi, MD | Contact | +39574434647 | marco.scatizzi@usl4.toscana.it |
| Name | Affiliation | Role |
|---|---|---|
| Marco Scatizzi, MD | Misericordia and Dolce Hospital | Study Chair |
| Marco Rettori, MD | Misericordia and Dolce Hospital | Study Director |
| Francesco Feroci, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misericordia and Dolce Hodpital | Recruiting | Prato | Po | 59100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19092351 | Result | Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| saline solution | Drug | 20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous |
|
| Thyroidectomy, total or partial | Procedure | Surgical standard intervention |
|
| Misericordia and Dolce Hospital |
| Principal Investigator |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| D013965 | Thyroidectomy |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided