Does Dexamethasone Improve Perioperative Outcomes?

Phase 1

• Conditions: surgery is associated with a number of routine side effects including severe fatigue, mood disturbances, ileus, fever, and hyperalgesia. The cumulative effect of these surgical sequelae is substantial because they disturb patients and delay return to normal activities including work.

• Registration Number: EUCTR2005-004222-10-AT
• Lead Sponsor: AKH Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-17
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patienst scheduled for open abdominal surgery scheduled to last more than two hours. All patients between 18 and 80 years old, all races, and both sexes will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of steroids or non-steroidal anti-inflammatory drugs within 48 hours of surgery, hypersensitivity to dexamthasone, latent amoebiasis or tuberculosis, cancer chemotherapy, caner with expectancy of life less than 6 months and decompensated diabetes mellitus. We also will exclude patients having history of fever, infection, dysautonomia, clinical relevant thyroid disease, obesity, Raynaud´s syndrome, or susceptibility to malignant hyperhtermia. Patients will also be excluded if they have Crohn´s disease, a history of abdominal radiation therapy, myasthenia gravis, or prior treatment with vinca alkaloids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified