School of Pharmaceutical Science
São Paulo, 05508-900, Brazil
Completed
NCT Number: NCT01564420
Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling
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.
Completed
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Postoperative pain
Time frame: two days
From the end of surgery until 36 hours of postoperative period
-
PK/PD modelling
Time frame: 2 days
From the begin of surgery until 36 hours of postoperative period
Secondary outcomes
-
PK parameter: Cmax (peak plasma concentration)
Time frame: 2 days
from the begin of surgery until 36 hours of postoperative period
-
PK parameter: Tmax (time to achieve the maximum concentration)
Time frame: 2 days
from the begin of surgery until 36 hours of postoperative period
-
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
Sponsors and collaborators
Lead sponsor
University of Sao Paulo
Other
Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Fundação de Amparo à Pesquisa do Estado de São Paulo
Registry information
Official study 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
Important dates
- Study start
- 2003
- Primary completion
- 2006
- First posted
- Mar 27, 2012
- Registry last updated
- Mar 27, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.