Malignant Neoplasm of Thyroid Clinical Trial
Official title:
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
| Verified date | August 2011 |
| Source | Università degli Studi dell'Aquila |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.
| Status | Completed |
| Enrollment | 328 |
| Est. completion date | March 2012 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 75 Years |
| Eligibility |
Inclusion Criteria: - patients undergoing thyroid surgery Exclusion Criteria: - ASA physical class III or IV - age > 75 years - pregnancy |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria | L'Aquila | AQ |
| Lead Sponsor | Collaborator |
|---|---|
| Università degli Studi dell'Aquila |
Italy,
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02645786 -
Thyrotropin Over-suppression and Heart
|
N/A |