Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

Pharmacokinetic/Pharmacodynamic Modeling of Morphine for Postoperative Analgesia Through a Patient Controlled Device After Coronary Artery Bypass Grafting. Intrathecal Morphine Significantly Reduces Drug Consumption

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01564420

Enrollment

Registered

2012-03-27

Start date

2003-01-31

Completion date

Unknown

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonar Artery Bypass Grafting

Keywords

pharmacokinetic/pharmacodynamic modeling, intrathecal morphine, postoperative analgesia, patient-controlled analgesia device

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	two days	From the end of surgery until 36 hours of postoperative period
PK/PD modelling	2 days	From the begin of surgery until 36 hours of postoperative period

Secondary

Measure	Time frame	Description
PK parameter: Cmax (peak plasma concentration)	2 days	from the begin of surgery until 36 hours of postoperative period
PK parameter: Tmax (time to achieve the maximum concentration)	2 days	from the begin of surgery until 36 hours of postoperative period
PK parameter: AUC (area under the plasma cocentration versus time curve)	2 days	from the begin of surgery until 36 hours of postoperative period

Countries

Brazil

Outcome results