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Clinical Trials/NCT01564420
NCT01564420CompletedNot Applicable

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

University of Sao Paulo1 site in 1 country36 target enrollmentStarted: January 2003Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
PK/PD modelling

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

PK/PD modelling

Time Frame: 2 days

From the begin of surgery until 36 hours of postoperative period

Postoperative pain

Time Frame: two days

From the end of surgery until 36 hours of postoperative period

Secondary Outcomes

  • PK parameter: Tmax (time to achieve the maximum concentration)(2 days)
  • PK parameter: Cmax (peak plasma concentration)(2 days)
  • PK parameter: AUC (area under the plasma cocentration versus time curve)(2 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Silvia Regina Cavani Jorge Santos

Chair Professor

University of Sao Paulo

Study Sites (1)

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