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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal morphine | Patients were randomized for general anesthesia, and allocated in the control group and morphine intrathecal group. | ||
| Control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | From the end of surgery until 36 hours of postoperative period | two days |
| PK/PD modelling | From the begin of surgery until 36 hours of postoperative period | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Cmax (peak plasma concentration) | from the begin of surgery until 36 hours of postoperative period | 2 days |
| PK parameter: Tmax (time to achieve the maximum concentration) | from the begin of surgery until 36 hours of postoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with coronary artery disease, eligible to cardiopulmonary artery bypass grafting surgery
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| Name | Affiliation | Role |
|---|---|---|
| Silvia RCJ Santos, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Pharmaceutical Science | São Paulo | São Paulo | 05508-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19488583 | Result | dos Santos LM, Santos VC, Santos SR, Malbouisson LM, Carmona MJ. Intrathecal morphine plus general anesthesia in cardiac surgery: effects on pulmonary function, postoperative analgesia, and plasma morphine concentration. Clinics (Sao Paulo). 2009;64(4):279-85. doi: 10.1590/s1807-59322009000400003. |
| Label | URL |
|---|---|
| Group web site | View source |
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For pharmacokinetic analysis, a serial of blood samples of patients was collected postoperatively after the extubation from a venous catheter (5mL each) into an EDTA tube (BD, Sao Paulo/Brazil) in the periods as follows: 0, 0.08, 0.25, 0.5, 1, 3, 6, 12, 18, 24 and 36 hrs. Blood samples were centrifuged at 2800 g for 20 minutes, plasma was transferred to labeled polyethylene vials and frozen at -80ºC until drug plasma assay.
| 2 days |
| PK parameter: AUC (area under the plasma cocentration versus time curve) | from the begin of surgery until 36 hours of postoperative period | 2 days |
| Health national council web site | View source |