Steroid Before Thyroidectomy

NCT00619086 — Not applicable, Completed, 72 participants, University of Bern

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Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?

Registry	NCT00619086
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple
Enrollment	72 (Actual)
Sponsor	University of Bern (Other)
Conditions	Thyroid Surgery for Benign Disease
Interventions	Dexamethason Helvepharm ®, Placebo (Drug)
Dates	start 2005-11-01, completion 2007-06-01, first posted 2008-02-20, last updated 2008-06-09
Locations	1 site in Switzerland

-Summary

We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.

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+Arms and interventions

Arm	Type	Interventions	Description
A, 1	Placebo comparator	Drug: Placebo	Placebo 45 minutes prior to surgery
A, 2	Active comparator	Drug: Dexamethason Helvepharm ®	8 mg Dexamethasone 45 minutes prior to surgery

Dexamethason Helvepharm ® (Drug): 8 mg Dexamethason i.v. 45 minutes prior to surgery
Placebo (Drug): 100 ml sodium chloride i.v. 45 minutes prior to surgery

+Outcome measures

Primary outcomes

Nausea [0-72 hours postoperative]

Secondary outcomes

Pain, vocal function [0-72 hours postoperative]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients undergoing thyroid surgery for benign disease

Exclusion Criteria:

* Depression
* Chronic pain disorder
* Insulin dependent diabetes mellitus
* History of PONV
* Pregnancy
* Age < 18 years
* Received antiemetic therapy within 48 hours

+Locations (1)

Facility	City	Country	Status
Department of visceral- and transplant surgery	Bern	Switzerland

+Publications

Results publication: 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 19092351

+Investigators

Stephan A. Vorburger, MD, Principal investigator, Dept of visceral- and transplant surgery, University Hospital Bern

My Notes

Public

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