Pharmacokinetic/Pharmacodynamic Modeling of Morphine for Postoperative Analgesia Through a Patient Controlled Device After Coronary Artery Bypass Grafting. Intrathecal Morphine Significantly Reduces Drug Consumption
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- PK/PD modelling
Study Overview
Brief Summary
The currently available data are insufficient to develop a model that achieves optimum morphine dose individualization at the postoperative period of coronary artery bypass grafting (CABG). Therefore, the objective of the study was to apply a PK/PD model that could justify morphine consumption, drug plasma concentration and pain intensity during the postoperative period after CABG and evaluate the post operative pain.
Detailed Description
The protocol was a prospective, open-label study, approved by the institutional ethical committee of the hospital where the study was performed. Patients were randomly assigned to receive general anesthesia plus intrathecal morphine at a dosage of 400 mcg (morphine group) or general anesthesia alone (control group) according to a simple computer-generated list.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •eligible to cardiopulmonary artery bypass grafting surgery
Exclusion Criteria
- •fraction of ejection below 40%
- •contraindications to neuraxial blockage
- •coagulopathy
- •use of low-weight heparin
- •warfarin or a platelet aggregation inhibitor other than aspirin,
- •systemic or local infection
- •and patients with a specific contraindication on the medication employed in the study
Outcomes
Primary Outcomes
PK/PD modelling
Time Frame: 2 days
From the begin of surgery until 36 hours of postoperative period
Postoperative pain
Time Frame: two days
From the end of surgery until 36 hours of postoperative period
Secondary Outcomes
- PK parameter: Tmax (time to achieve the maximum concentration)(2 days)
- PK parameter: Cmax (peak plasma concentration)(2 days)
- PK parameter: AUC (area under the plasma cocentration versus time curve)(2 days)
Investigators
Silvia Regina Cavani Jorge Santos
Chair Professor
University of Sao Paulo