Cardiopulmonar Artery Bypass GraftingNCT01564420
Morphine Postoperative Analgesia and Pharmacokinetic/Pharmacodynamic Modeling
An observational study of Cardiopulmonar Artery Bypass Grafting, run by University of Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonar Artery Bypass Grafting
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2003to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease, eligible to cardiopulmonary artery bypass grafting surgery
Who may be able to join
- eligible to cardiopulmonary artery bypass grafting surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiopulmonar Artery Bypass Grafting
- Keywords
- pharmacokinetic/pharmacodynamic modeling, intrathecal morphine, postoperative analgesia, patient-controlled analgesia device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Patients were randomized for general anesthesia, and allocated in the control group and morphine intrathecal group. | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
From the end of surgery until 36 hours of postoperative period
Measured: two days
PK/PD modelling
From the begin of surgery until 36 hours of postoperative period
Measured: 2 days
Secondary outcomes (3)
PK parameter: Cmax (peak plasma concentration)
from the begin of surgery until 36 hours of postoperative period
Measured: 2 days
PK parameter: Tmax (time to achieve the maximum concentration)
from the begin of surgery until 36 hours of postoperative period
Measured: 2 days
PK parameter: AUC (area under the plasma cocentration versus time curve)
from the begin of surgery until 36 hours of postoperative period
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJan 2003
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonar Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Silvia Regina Cavani Jorge Santos, University of Sao Paulo
- Investigators
- Silvia RCJ Santos, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564420
- Sponsor's protocol ID
- Santos 2012
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
dos Santos LM, Santos VC, Santos SR, Malbouisson LM, Carmona MJ. Intrathecal morphine plus general anesthesia in cardiac surgery: effects on pulmonary function, postoperative analgesia, and plasma morphine concentration. Clinics (Sao Paulo). 2009;64(4):279-85. doi: 10.1590/s1807-59322009000400003.
PubMed 19488583
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01564420
- Acronym / sponsor ID
- Santos 2012
- Conditions
- Cardiopulmonar Artery Bypass Grafting
- Keywords
- pharmacokinetic/pharmacodynamic modeling, intrathecal morphine, postoperative analgesia, patient-controlled analgesia device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2003
- Primary completion
- Dec 2006 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | – | –Patients were randomized for general anesthesia, and allocated in the control group and morphine intrathecal group. |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease, eligible to cardiopulmonary artery bypass grafting surgery
Key inclusion criteria (1 listed)
- eligible to cardiopulmonary artery bypass grafting surgery
Key exclusion criteria (7 listed)
- fraction of ejection below 40%
- contraindications to neuraxial blockage
- coagulopathy
- use of low-weight heparin
- warfarin or a platelet aggregation inhibitor other than aspirin,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
PK parameter: Cmax (peak plasma concentration)
Time frame: 2 days
PK parameter: Tmax (time to achieve the maximum concentration)
Time frame: 2 days
PK parameter: AUC (area under the plasma cocentration versus time curve)
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
- Results publication: PubMed 19488583dos Santos LM, Santos VC, Santos SR, Malbouisson LM, Carmona MJ. Intrathecal morphine plus general anesthesia in cardiac surgery: effects on pulmonary function, postoperative analgesia, and plasma morphine concentration. Clinics (Sao Paulo). 2009;64(4):279-85. doi: 10.1590/s1807-59322009000400003.
- Group web siteLink provided by the sponsor.
- Health national council web siteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia RCJ Santos, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonar Artery Bypass Grafting, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: two days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01564420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.