Text Size

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

This study is currently recruiting participants.
Verified September 2012 by Ospedale Misericordia e Dolce
Sponsor:
Information provided by (Responsible Party):
Marco Scatizzi, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT00888303
First received: April 23, 2009
Last updated: September 1, 2012
Last verified: September 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

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: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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
Study First Received: April 23, 2009
Last Updated: September 1, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Nausea
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Vomiting
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013