Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiopulmonar Artery Bypass Grafting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

No interventions assigned to this group

Intrathecal morphine

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No