This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Steroid Before Thyroidectomy

This study has been completed.
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00619086
First received: February 7, 2008
Last updated: June 6, 2008
Last verified: June 2008
  Purpose
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 Intervention
Thyroid Surgery for Benign Disease Drug: Dexamethason Helvepharm ® Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Official Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?

Resource links provided by NLM:


Further study details as provided by University of Bern:

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

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

Enrollment: 72
Study Start Date: November 2005
Study Completion Date: June 2007
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: February 7, 2008
Last Updated: June 6, 2008

Keywords provided by University of Bern:
thyroidectomy
dexamethasone
steroid
nausea

ClinicalTrials.gov processed this record on June 28, 2017