Coronary Artery DiseaseNCT00622791
Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass
An observational study of Coronary Artery Disease and Cardiopulmonary Bypass, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Cardiopulmonary Bypass, Coronary Artery Bypass Graft
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- 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: Twenty patients undergoing elective coronary artery bypass graft surgery
Who may be able to join
- Isolated coronary artery bypass indication
- Left ventricular ejection fraction greater than 50 %
- Absence of preoperative pulmonary dysfunction
Who cannot join
- Intra and postoperative circulatory shock
- Postoperative pulmonary dysfunction
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery
Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.
Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.
- Keywords
- Cardiopulmonary bypass, coronary artery bypass graft, coronary artery disease, propofol, pharmacokinetics, pharmacodynamics
- Medical subject headings
- Coronary Artery Disease
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 |
|---|---|---|
| CABG group | Patients undergoing coronary artery bypass graft with cardiopulmonary bypass | |
| OPCAB group | Patients undergoing off-pump coronary artery bypass graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol pharmacodynamics and pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
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 Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- Investigators
- Maria M Carmona, MD PhD, Principal investigator, Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622791
- Sponsor's protocol ID
- 802-01
- Status last verified
- Feb 2008
- First submitted
- 13 Feb 2008
- Last updated
- 25 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barbosa RA, Santos SR, White PF, Pereira VA, Silva Filho CR, Malbouisson LM, Carmona MJ. Effects of cardiopulmonary bypass on propofol pharmacokinetics and bispectral index during coronary surgery. Clinics (Sao Paulo). 2009;64(3):215-21. doi: 10.1590/s1807-59322009000300012.
PubMed 19330248
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery
- ClinicalTrials.gov ID
- NCT00622791
- Acronym / sponsor ID
- 802-01
- Keywords
- Cardiopulmonary bypass, coronary artery bypass graft, coronary artery disease, propofol, pharmacokinetics, pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- First posted
- 25 Feb 2008 (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.
Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.
Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG group | – | –Patients undergoing coronary artery bypass graft with cardiopulmonary bypass |
| OPCAB group | – | –Patients undergoing off-pump coronary artery bypass graft |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty patients undergoing elective coronary artery bypass graft surgery
Key inclusion criteria (3 listed)
- Isolated coronary artery bypass indication
- Left ventricular ejection fraction greater than 50 %
- Absence of preoperative pulmonary dysfunction
Key exclusion criteria (2 listed)
- Intra and postoperative circulatory shock
- Postoperative pulmonary dysfunction
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
Propofol pharmacodynamics and pharmacokinetics
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 25 Feb 2008.
- Derived from this study: PubMed 19330248Barbosa RA, Santos SR, White PF, Pereira VA, Silva Filho CR, Malbouisson LM, Carmona MJ. Effects of cardiopulmonary bypass on propofol pharmacokinetics and bispectral index during coronary surgery. Clinics (Sao Paulo). 2009;64(3):215-21. doi: 10.1590/s1807-59322009000300012.
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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.
Maria M Carmona, MD PhD principal investigator
Faculdade de Medicina da Universidade de São 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 Coronary Artery Disease and Cardiopulmonary Bypass, 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 3 inclusion and 2 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 25 Feb 2008. 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?
Propofol pharmacodynamics and pharmacokinetics. 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 NCT00622791, 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 25 Feb 2008.