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Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00622791
Enrollment
20
Registered
2008-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2008-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass, Coronary Artery Bypass Graft, Coronary Artery Disease

Keywords

Cardiopulmonary bypass, coronary artery bypass graft, coronary artery disease, propofol, pharmacokinetics, pharmacodynamics

Brief 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. 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.

Interventions

None listed

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Propofol pharmacodynamics and pharmacokinetics

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026