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Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564420
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Silvia Regina Cavani Jorge Santos, 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.

Condition or disease
Cardiopulmonar Artery Bypass Grafting

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.

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pharmacokinetic/Pharmacodynamic Modeling of Morphine for Postoperative Analgesia Through a Patient Controlled Device After Coronary Artery Bypass Grafting. Intrathecal Morphine Significantly Reduces Drug Consumption
Study Start Date : January 2003
Actual Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine


Group/Cohort
Intrathecal morphine
Patients were randomized for general anesthesia, and allocated in the control group and morphine intrathecal group.
Control group



Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: two days ]
    From the end of surgery until 36 hours of postoperative period

  2. PK/PD modelling [ Time Frame: 2 days ]
    From the begin of surgery until 36 hours of postoperative period


Secondary Outcome Measures :
  1. PK parameter: Cmax (peak plasma concentration) [ Time Frame: 2 days ]
    from the begin of surgery until 36 hours of postoperative period

  2. PK parameter: Tmax (time to achieve the maximum concentration) [ Time Frame: 2 days ]
    from the begin of surgery until 36 hours of postoperative period

  3. PK parameter: AUC (area under the plasma cocentration versus time curve) [ Time Frame: 2 days ]
    from the begin of surgery until 36 hours of postoperative period


Biospecimen Retention:   Samples Without DNA
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.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease, eligible to cardiopulmonary artery bypass grafting surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564420


Locations
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Brazil
School of Pharmaceutical Science
Sao Paulo, Brazil, 05508-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Silvia RCJ Santos, PhD University of Sao Paulo
Additional Information:
Publications of Results:
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Responsible Party: Silvia Regina Cavani Jorge Santos, Chair Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01564420    
Other Study ID Numbers: Santos 2012
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012
Keywords provided by Silvia Regina Cavani Jorge Santos, University of Sao Paulo:
pharmacokinetic/pharmacodynamic modeling
intrathecal morphine
postoperative analgesia
patient-controlled analgesia device