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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00888303 |
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Date of registration:
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23/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function
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Scientific title:
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Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease. |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00888303 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Francesco Feroci, MD |
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Address:
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Telephone:
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+393398382381 |
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Email:
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fferoci@yahoo.it |
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Affiliation:
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Name:
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Marco Scatizzi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Misericordia and Dolce Hospital |
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Name:
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Francesco Feroci, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Misericordia and Dolce Hospital |
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Name:
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Francesco Feroci, MD |
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Address:
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Telephone:
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+393389592375 |
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Email:
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fferoci@yahoo.it |
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Affiliation:
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Name:
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Marco Rettori, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Misericordia and Dolce Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Vocal Function
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Thyroidectomy
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Postoperative Pain
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Postoperative Nausea and Vomit
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Intervention(s)
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Drug: Dexamethasone
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Drug: saline solution
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Procedure: Thyroidectomy, total or partial
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Primary Outcome(s)
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Postoperative nausea and vomit (PONV) measured in 4 grades
[Time Frame: 8, 24, 32 and 48 hours after surgery]
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Secondary Outcome(s)
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Vocal function measured in a 0-100 Visual analog scale
[Time Frame: 8, 24, 32 and 48 hours after surgery]
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Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale
[Time Frame: 8, 24, 32 and 48 hours after surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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