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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
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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)
Groups/Cohorts
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

  Eligibility

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

Criteria

Inclusion Criteria:

  • patients undergoing thyroid surgery

Exclusion Criteria:

  • ASA physical class III or IV
  • age > 75 years
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690806

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

No publications provided

Responsible Party: CECILIA Emanuela Marina, M.D., Università degli Studi dell'Aquila
ClinicalTrials.gov 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:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Brain Neoplasms
Vocal Cord Paralysis
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Laryngeal Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics

ClinicalTrials.gov processed this record on June 18, 2013