Patient between 18 and 70 years old undergoing major abdominal surgery through a midline incision.
Conditions
Interventions
Product Name: S-Ketamine
Product Code: RVG 22550
Pharmaceutical Form: Intravenous infusion
Sponsors
None
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.the patient has provided written informed consent prior to admission to the study 2.the patient is between 18 and 70 years of age 3.the patient’s BMI is less than 32 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: 1.the patient has a history of uncontrolled chronic disease which would contraindicate study participation 2.the patient has severe systemic disease that limits activity and is a constant threat to life (ASA IV) 3.the patient has a history of chronic substance abuse within the last 3 months 4.the patient is taking has a history of psychiatric disorders 5.the patient has a history of hypersensitivity to one of the study drugs 6.the patient has a history of severe chronic respiratory disorders 7.the patient is either breastfeeding or pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. The VAS scores per study group. 2. The total morphine use over 72 hours. 3. The occurence of side effects.;Main Objective: To compare the analgesic potential of all four therapies (VAS Scores) To compare the morphine sparing effect of low-dose ketamine in peroperative infusion and in post operative PCA (Morphine use) To compare the occurence of side effects. ;Secondary Objective: To evaluate the effect of the therapies on the levels of amino-acids | — |
Countries
Netherlands
Outcome results
None listed