Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy

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

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.

Benign Neoplasm of Thyroid Gland
Malignant Neoplasm of Thyroid

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.

Resource links provided by NLM:

Further study details as provided by Università degli Studi dell'Aquila:

Enrollment: 328
Study Start Date: January 2008
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp & Dohme) intravenously 90 min before skin incision
Patients who receive saline placebo intravenously 90 min before skin incision


Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients undergoing thyroid surgery for benign and malignant thyroidal disease


Inclusion Criteria:

  • patients undergoing thyroid surgery

Exclusion Criteria:

  • ASA physical class III or IV
  • age > 75 years
  • pregnancy
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Please refer to this study by its identifier: NCT01690806

ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria
L'Aquila, AQ, Italy, 67100
Sponsors and Collaborators
Università degli Studi dell'Aquila
Principal Investigator: Emanuela M CECILIA, M.D. Università degli Studi dell'Aquila
  More Information

No publications provided by Università degli Studi dell'Aquila

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: CECILIA Emanuela Marina, M.D., Università degli Studi dell'Aquila Identifier: NCT01690806     History of Changes
Other Study ID Numbers: OTO: OTO12-0447R
Study First Received: September 19, 2012
Last Updated: September 25, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Vocal Cord Paralysis
Thyroid Neoplasms
Cranial Nerve Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Laryngeal Diseases
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms
Thyroid Diseases
Vagus Nerve Diseases
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions processed this record on March 31, 2015