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

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomit, Postoperative Vocal Function

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Dexamethasone
saline solution
Thyroidectomy, total or partial
Sponsored by
Ospedale Misericordia e Dolce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Misericordia and Dolce HodpitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A (dexamethasone)

B (Control)

Arm Description

20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered

20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous

Outcomes

Primary Outcome Measures

Postoperative nausea and vomit (PONV) measured in 4 grades

Secondary Outcome Measures

Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale
Vocal function measured in a 0-100 Visual analog scale

Full Information

First Posted
April 23, 2009
Last Updated
September 1, 2012
Sponsor
Ospedale Misericordia e Dolce
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1. Study Identification

Unique Protocol Identification Number
NCT00888303
Brief Title
Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea and Vomit, Postoperative Vocal Function, Thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (dexamethasone)
Arm Type
Active Comparator
Arm Description
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
Arm Title
B (Control)
Arm Type
Placebo Comparator
Arm Description
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
Intervention Type
Drug
Intervention Name(s)
saline solution
Intervention Description
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
Intervention Type
Procedure
Intervention Name(s)
Thyroidectomy, total or partial
Intervention Description
Surgical standard intervention
Primary Outcome Measure Information:
Title
Postoperative nausea and vomit (PONV) measured in 4 grades
Time Frame
8, 24, 32 and 48 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale
Time Frame
8, 24, 32 and 48 hours after surgery
Title
Vocal function measured in a 0-100 Visual analog scale
Time Frame
8, 24, 32 and 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Feroci, MD
Phone
+393398382381
Email
fferoci@yahoo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Scatizzi, MD
Phone
+39574434647
Email
marco.scatizzi@usl4.toscana.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Scatizzi, MD
Organizational Affiliation
Misericordia and Dolce Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marco Rettori, MD
Organizational Affiliation
Misericordia and Dolce Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francesco Feroci, MD
Organizational Affiliation
Misericordia and Dolce Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misericordia and Dolce Hodpital
City
Prato
State/Province
Po
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Feroci, MD
Phone
+393389592375
Email
fferoci@yahoo.it
First Name & Middle Initial & Last Name & Degree
Francesco Feroci, MD
First Name & Middle Initial & Last Name & Degree
Andrea Borrelli, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19092351
Citation
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. doi: 10.1097/SLA.0b013e31818c709a.
Results Reference
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Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function

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