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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Nausea [ Time Frame: 0-72 hours postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain, vocal function [ Time Frame: 0-72 hours postoperative ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided by University of Bern

Additional 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
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University of Bern:
thyroidectomy
dexamethasone
steroid
nausea

Additional relevant MeSH terms:
Dexamethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013