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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00619086
Other study ID # KEK_49_05
Secondary ID
Status Completed
Phase N/A
First received February 7, 2008
Last updated June 6, 2008
Start date November 2005
Est. completion date June 2007

Study information

Verified date June 2008
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)


Related Conditions & MeSH terms

  • Thyroid Surgery for Benign Disease

Intervention

Drug:
Dexamethason Helvepharm ®
8 mg Dexamethason i.v. 45 minutes prior to surgery
Placebo
100 ml sodium chloride i.v. 45 minutes prior to surgery

Locations

Country Name City State
Switzerland Department of visceral- and transplant surgery Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nausea 0-72 hours postoperative No
Secondary Pain, vocal function 0-72 hours postoperative No