Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

Completed

• Conditions: Cardiopulmonar Artery Bypass Grafting

• Registration Number: NCT01564420
• Lead Sponsor: University of Sao Paulo

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Last Update Submitted: 2012-03-23
• Study First Posted: 2012-03-27
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• eligible to cardiopulmonary artery bypass grafting surgery

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PK parameter: Tmax (time to achieve the maximum concentration)	2 days	from the begin of surgery until 36 hours of postoperative period
PK parameter: Cmax (peak plasma 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

Trial Locations

Locations (1)

School of Pharmaceutical Science; 🇧🇷 Sao Paulo, Brazil