Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622791
• Other study ID #: 802-01
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: February 13, 2008

Study information

• Verified date: February 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Coronary Artery Bypass Graft
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Brazil	Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Propofol pharmacodynamics and pharmacokinetics			No