Steroid Before Thyroidectomy

June 6, 2008 updated by: University of Bern

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of visceral- and transplant surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A, 1
Placebo 45 minutes prior to surgery
Drug: Placebo
100 ml sodium chloride i.v. 45 minutes prior to surgery
Active Comparator: A, 2
8 mg Dexamethasone 45 minutes prior to surgery
Drug: Dexamethason Helvepharm ®
8 mg Dexamethason i.v. 45 minutes prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nausea
Time Frame: 0-72 hours postoperative
0-72 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain, vocal function
Time Frame: 0-72 hours postoperative
0-72 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 9, 2008

Last Update Submitted That Met QC Criteria

June 6, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KEK_49_05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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