Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

University of Sao Paulo

Status: Completed

Conditions: Cardiopulmonar Artery Bypass Grafting

Study type: Observational

Funder types: Other

Identifiers

NCT01564420

Santos 2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 2 patient groups

Intrathecal morphine

Description:

Patients were randomized for general anesthesia, and allocated in the control group and morphine intrathecal group.

Control group