Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

University of Sao Paulo

Status: Completed

Conditions: Coronary Artery Disease; Coronary Artery Bypass Graft; Cardiopulmonary Bypass

Study type: Observational

Funder types: Other

Identifiers

NCT00622791

802-01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

CABG group

Description:

Patients undergoing coronary artery bypass graft with cardiopulmonary bypass

OPCAB group

Description:

Patients undergoing off-pump coronary artery bypass graft