Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CECILIA Emanuela Marina, Università degli Studi dell'Aquila
ClinicalTrials.gov Identifier:
NCT01690806
First received: September 19, 2012
Last updated: September 25, 2012
Last verified: August 2011

September 19, 2012
September 25, 2012
January 2008
January 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01690806 on ClinicalTrials.gov Archive Site
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Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

patients undergoing thyroid surgery for benign and malignant thyroidal disease

  • Benign Neoplasm of Thyroid Gland
  • Malignant Neoplasm of Thyroid
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  • dexamethasone
    Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp & Dohme) intravenously 90 min before skin incision
  • placebo
    Patients who receive saline placebo intravenously 90 min before skin incision
Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Lancione L, Amicucci G. Dexamethasone for the prevention of recurrent laryngeal nerve palsy and other complications after thyroid surgery: a randomized double-blind placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 May;139(5):471-8. doi: 10.1001/jamaoto.2013.2821.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
March 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing thyroid surgery

Exclusion Criteria:

  • ASA physical class III or IV
  • age > 75 years
  • pregnancy
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01690806
OTO: OTO12-0447R
Yes
CECILIA Emanuela Marina, Università degli Studi dell'Aquila
Università degli Studi dell'Aquila
Not Provided
Principal Investigator: Emanuela M CECILIA, M.D. Università degli Studi dell'Aquila
Università degli Studi dell'Aquila
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP