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.
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 Type
OBSERVATIONAL
Enrollment
36
School of Pharmaceutical Science
São Paulo, São Paulo, Brazil
Postoperative pain
From the end of surgery until 36 hours of postoperative period
Time frame: two days
PK/PD modelling
From the begin of surgery until 36 hours of postoperative period
Time frame: 2 days
PK parameter: Cmax (peak plasma concentration)
from the begin of surgery until 36 hours of postoperative period
Time frame: 2 days
PK parameter: Tmax (time to achieve the maximum concentration)
from the begin of surgery until 36 hours of postoperative period
Time frame: 2 days
PK parameter: AUC (area under the plasma cocentration versus time curve)
from the begin of surgery until 36 hours of postoperative period
Time frame: 2 days
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