NCT00888303

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_2 postoperative-pain

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

April 23, 2009

Last Update Submit

September 1, 2012

Conditions

Postoperative PainPostoperative Nausea and VomitPostoperative Vocal FunctionThyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative nausea and vomit (PONV) measured in 4 grades

    8, 24, 32 and 48 hours after surgery

Secondary Outcomes (2)

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

    8, 24, 32 and 48 hours after surgery

  • Vocal function measured in a 0-100 Visual analog scale

    8, 24, 32 and 48 hours after surgery

Study Arms (2)

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: DexamethasoneProcedure: Thyroidectomy, total or partial

B (Control)

PLACEBO COMPARATOR

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

Drug: saline solutionProcedure: Thyroidectomy, total or partial

Interventions

DexamethasoneDRUG

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

A (dexamethasone)
saline solutionDRUG

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

B (Control)
Thyroidectomy, total or partialPROCEDURE

Surgical standard intervention

A (dexamethasone)B (Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Patients undergoing thyroidectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misericordia and Dolce Hodpital

Prato, Po, 59100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19092351RESULT

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingVomiting

Interventions

DexamethasoneSaline SolutionThyroidectomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsEndocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Scatizzi, MD

    Misericordia and Dolce Hospital

    STUDY CHAIR

  • Marco Rettori, MD

    Misericordia and Dolce Hospital

    STUDY DIRECTOR

  • Francesco Feroci, MD

    Misericordia and Dolce Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Feroci, MD

CONTACT

+393398382381fferoci@yahoo.it

Marco Scatizzi, MD

CONTACT

+39574434647marco.scatizzi@usl4.toscana.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 27, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

IT(1)