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Steroid Before Thyroidectomy

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ClinicalTrials.gov Identifier: NCT00619086
Recruitment Status : Completed
First Posted : February 20, 2008
Last Update Posted : June 9, 2008
Sponsor:
Information provided by:
University of Bern

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroid Surgery for Benign Disease Drug: Dexamethason Helvepharm ® Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
Study Start Date : November 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Nausea [ Time Frame: 0-72 hours postoperative ]

Secondary Outcome Measures :
  1. Pain, vocal function [ Time Frame: 0-72 hours postoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619086


Locations
Switzerland
Department of visceral- and transplant surgery
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Stephan A. Vorburger, MD Dept of visceral- and transplant surgery, University Hospital Bern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Candinas Daniel, MD, Department of Visceral- and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00619086     History of Changes
Other Study ID Numbers: KEK_49_05
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: June 9, 2008
Last Verified: June 2008

Keywords provided by University of Bern:
thyroidectomy
dexamethasone
steroid
nausea