Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function - Full Text View

Sponsored by:	Ospedale Misericordia e Dolce
Information provided by:	Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:	NCT00888303

Purpose

The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.

Condition	Intervention	Phase
Postoperative Pain Postoperative Nausea and Vomit Postoperative Vocal Function Thyroidectomy	Drug: Dexamethasone Drug: saline solution Procedure: Thyroidectomy, total or partial	Phase II

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease.

Further study details as provided by Ospedale Misericordia e Dolce:

Primary Outcome Measures:

Postoperative nausea and vomit (PONV) measured in 4 grades [ Time Frame: 8, 24, 32 and 48 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale [ Time Frame: 8, 24, 32 and 48 hours after surgery ] [ Designated as safety issue: No ]
Vocal function measured in a 0-100 Visual analog scale [ Time Frame: 8, 24, 32 and 48 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A (dexamethasone): Active Comparator 20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered	Drug: Dexamethasone 20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered Procedure: Thyroidectomy, total or partial Surgical standard intervention
B (Control): Placebo Comparator 20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous	Drug: saline solution 20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous Procedure: Thyroidectomy, total or partial Surgical standard intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years
Patients undergoing thyroidectomy

Exclusion Criteria:

Patients who had received antiemetic therapy within 48 hours before surgery
Patients with depression
Chronic pain disorder
Insulin-dependent diabetes mellitus
History of severe and/or repeated PONV after previous minor surgery, that led to change from standard anesthetic protocol
Pregnancy
Age < 18 years
Patients who had known malignant disease or had undergone previous thyroid or neck surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888303

Contacts

Contact: Francesco Feroci, MD	+393398382381	fferoci@yahoo.it
Contact: Marco Scatizzi, MD	+39574434647	marco.scatizzi@usl4.toscana.it

Locations

Italy, Po
Misericordia and Dolce Hodpital	Recruiting
Prato, Po, Italy, 59100
Contact: Francesco Feroci, MD +393389592375 fferoci@yahoo.it
Principal Investigator: Francesco Feroci, MD
Sub-Investigator: Andrea Borrelli, MD

Sponsors and Collaborators

Ospedale Misericordia e Dolce

Investigators

Study Chair:	Marco Scatizzi, MD	Misericordia and Dolce Hospital
Study Director:	Marco Rettori, MD	Misericordia and Dolce Hospital
Principal Investigator:	Francesco Feroci, MD	Misericordia and Dolce Hospital

More Information

Publications:

Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6.

Responsible Party:	Misericordia and Dolce Hospital ( Francesco Feroci )
Study ID Numbers:	MD123
Study First Received:	April 23, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00888303 History of Changes
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Postoperative Nausea and Vomiting
Vomiting
Antineoplastic Agents, Hormonal
Signs and Symptoms, Digestive
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics

Pain
Hormones
Glucocorticoids
Signs and Symptoms
Postoperative Complications
Nausea
Peripheral Nervous System Agents
Pain, Postoperative
Dexamethasone acetate

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Vomiting
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Pain
Hormones
Signs and Symptoms
Pathologic Processes
Therapeutic Uses

Nausea
Dexamethasone acetate
Pain, Postoperative
Postoperative Nausea and Vomiting
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Postoperative Complications
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009