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

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00888303
• Other study ID #: MD123
• Status: Recruiting
• Phase: Phase 2
• First received: April 23, 2009
• Last updated: September 1, 2012
• Start date: January 2009
• Est. completion date: October 2012

Study information

• Verified date: September 2012
• Source: Ospedale Misericordia e Dolce
• Contact: Francesco Feroci, MD
• Phone: +393398382381
• Email: fferoci[@]yahoo.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomit
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Postoperative Vocal Function
• Thyroidectomy

Intervention

Drug:
• Dexamethasone
20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered
• saline solution
20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous

Procedure:
• Thyroidectomy, total or partial
Surgical standard intervention

Locations

Country	Name	City	State
Italy	Misericordia and Dolce Hodpital	Prato	Po

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Misericordia e Dolce

Country where clinical trial is conducted

Italy, 

References & 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomit (PONV) measured in 4 grades		8, 24, 32 and 48 hours after surgery	No
Secondary	Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale		8, 24, 32 and 48 hours after surgery	No
Secondary	Vocal function measured in a 0-100 Visual analog scale		8, 24, 32 and 48 hours after surgery	No