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

NCT ID: NCT00888303

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Postoperative Nausea and Vomit Postoperative Vocal Function Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A (dexamethasone)

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Thyroidectomy, total or partial

Intervention Type PROCEDURE

Surgical standard intervention

B (Control)

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

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

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

Thyroidectomy, total or partial

Intervention Type PROCEDURE

Surgical standard intervention

Interventions

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Dexamethasone

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

saline solution

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

Intervention Type DRUG

Thyroidectomy, total or partial

Surgical standard intervention

Intervention Type PROCEDURE

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Misericordia e Dolce

OTHER

Sponsor Role lead

Responsible Party

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Marco Scatizzi

Md

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Scatizzi, MD

Role: STUDY_CHAIR

Misericordia and Dolce Hospital

Marco Rettori, MD

Role: STUDY_DIRECTOR

Misericordia and Dolce Hospital

Francesco Feroci, MD

Role: PRINCIPAL_INVESTIGATOR

Misericordia and Dolce Hospital

Locations

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Misericordia and Dolce Hodpital

Prato, Po, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Feroci, MD

Role: CONTACT

Phone: +393398382381

Email: [email protected]

Marco Scatizzi, MD

Role: CONTACT

Phone: +39574434647

Email: [email protected]

Facility Contacts

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Francesco Feroci, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 19092351 (View on PubMed)

Other Identifiers

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MD123

Identifier Type: -

Identifier Source: org_study_id