Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

NCT ID: NCT00622791

Last Updated: 2008-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Cardiopulmonary Bypass Coronary Artery Bypass Graft

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CABG group

Patients undergoing coronary artery bypass graft with cardiopulmonary bypass

No interventions assigned to this group

OPCAB group

Patients undergoing off-pump coronary artery bypass graft

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Isolated coronary artery bypass indication
* Left ventricular ejection fraction greater than 50 %
* Absence of preoperative pulmonary dysfunction

Exclusion Criteria

* Intra and postoperative circulatory shock
* Postoperative pulmonary dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Faculdade de Medicina da Universidade de São Paulo

Principal Investigators

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Maria M Carmona, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Medicina da Universidade de São Paulo

Locations

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Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 19330248 (View on PubMed)

Other Identifiers

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802-01

Identifier Type: -

Identifier Source: org_study_id

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