Steroid Before Thyroidectomy

NCT ID: NCT00619086

Last Updated: 2008-06-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Surgery for Benign Disease

Keywords

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thyroidectomy dexamethasone steroid nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A, 1

Placebo 45 minutes prior to surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 ml sodium chloride i.v. 45 minutes prior to surgery

A, 2

8 mg Dexamethasone 45 minutes prior to surgery

Group Type ACTIVE_COMPARATOR

Dexamethason Helvepharm ®

Intervention Type DRUG

8 mg Dexamethason i.v. 45 minutes prior to surgery

Interventions

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Dexamethason Helvepharm ®

8 mg Dexamethason i.v. 45 minutes prior to surgery

Intervention Type DRUG

Placebo

100 ml sodium chloride i.v. 45 minutes prior to surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Department of Visceral- and Transplantation Surgery

Principal Investigators

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Stephan A. Vorburger, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of visceral- and transplant surgery, University Hospital Bern

Locations

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Department of visceral- and transplant surgery

Bern, , Switzerland

Site Status

Countries

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Switzerland

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 DERIVED
PMID: 19092351 (View on PubMed)

Other Identifiers

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KEK_49_05

Identifier Type: -

Identifier Source: org_study_id