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

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ClinicalTrials.gov Identifier: NCT00888303
Recruitment Status : Unknown
Verified September 2012 by Marco Scatizzi, Ospedale Misericordia e Dolce.
Recruitment status was:  Recruiting
First Posted : April 27, 2009
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomit Postoperative Vocal Function Thyroidectomy Drug: Dexamethasone Drug: saline solution Procedure: Thyroidectomy, total or partial Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : January 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A (dexamethasone)
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
Placebo Comparator: B (Control)
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


Outcome Measures

Primary Outcome Measures :
  1. Postoperative nausea and vomit (PONV) measured in 4 grades [ Time Frame: 8, 24, 32 and 48 hours after surgery ]

Secondary Outcome Measures :
  1. Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale [ Time Frame: 8, 24, 32 and 48 hours after surgery ]
  2. Vocal function measured in a 0-100 Visual analog scale [ Time Frame: 8, 24, 32 and 48 hours after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00888303


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

Locations
Italy
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:
Responsible Party: Marco Scatizzi, Md, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00888303     History of Changes
Other Study ID Numbers: MD123
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Pain, Postoperative
Nausea
Postoperative Nausea and Vomiting
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Vomiting
Pharmaceutical Solutions
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action