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Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01690806
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):
CECILIA Emanuela Marina, Università degli Studi dell'Aquila

Brief Summary:
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.

Condition or disease
Benign Neoplasm of Thyroid Gland Malignant Neoplasm of Thyroid

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Study Type : Observational
Actual Enrollment : 328 participants
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.
Study Start Date : January 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01690806

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CECILIA Emanuela Marina, M.D., Università degli Studi dell'Aquila Identifier: NCT01690806     History of Changes
Other Study ID Numbers: OTO: OTO12-0447R
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: August 2011
Additional relevant MeSH terms:
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Thyroid Neoplasms
Vocal Cord Paralysis
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal