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.
Conditions
Interventions
Trade Name: Dexamethasone "Nycomed", 4mg Ampulle
Product Name: Dexamethasone 4mg
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Intravenous infusion
Rou
Sponsors
AKH Wien
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Inflammation in response to surgical tissue injury are likely causes of excessive postoperative fatigue, ileus and fever. Steroids as well as sympathetic blockade reduce inflammation. We therefore propose to test the hypothesus that dexamethasone 0,5 mg/kg decrases postoperative fatigue levels without deleterious side effects, whereas applying epidural anesthesia right after induction has no advantage over epidural at the end of surgery.;Secondary Objective: Ileus, fever, lenght of stay in hospital;Primary end point(s): 1. fever 2. ileus 3. fatigue 4. lenght of stay | — |
Countries
Austria
Outcome results
None listed