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Clinical Trials/NCT00622791
NCT00622791
Completed
N/A

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

University of Sao Paulo1 site in 1 country20 target enrollmentFebruary 25, 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Sao Paulo
Enrollment
20
Locations
1
Primary Endpoint
Propofol pharmacodynamics and pharmacokinetics
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2008
End Date
TBD
Last Updated
18 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Propofol pharmacodynamics and pharmacokinetics

Study Sites (1)

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