Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

328 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Neoplasm of Thyroid Gland Malignant Neoplasm of Thyroid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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dexamethasone

Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp \& Dohme) intravenously 90 min before skin incision

No interventions assigned to this group

placebo

Patients who receive saline placebo intravenously 90 min before skin incision

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients undergoing thyroid surgery

Exclusion Criteria

* ASA physical class III or IV
* age \> 75 years
* pregnancy

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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CECILIA Emanuela Marina

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emanuela M CECILIA, M.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Aquila

Locations

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ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria

L’Aquila, AQ, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED

PMID: 23681030 (View on PubMed)

Other Identifiers

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OTO: OTO12-0447R

Identifier Type: -

Identifier Source: org_study_id