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

Phase 2

• Conditions: Postoperative Pain; Postoperative Nausea and Vomit; Postoperative Vocal Function; Thyroidectomy
• Interventions: Drug: saline solution; Drug: Dexamethasone; Procedure: Thyroidectomy, total or partial

• Registration Number: NCT00888303
• Lead Sponsor: Ospedale Misericordia e Dolce

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-04-23
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-01
• Last Update Posted: 2012-09-05
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age > 18 years
• Patients undergoing thyroidectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (dexamethasone)	Thyroidectomy, total or partial	20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
B (Control)	saline solution	20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
B (Control)	Thyroidectomy, total or partial	20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous
A (dexamethasone)	Dexamethasone	20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomit (PONV) measured in 4 grades	8, 24, 32 and 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Misericordia and Dolce Hodpital; 🇮🇹 Prato, Po, Italy