Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00622791
First received: February 13, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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.


Condition
Coronary Artery Disease
Cardiopulmonary Bypass
Coronary Artery Bypass Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Propofol pharmacodynamics and pharmacokinetics [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples


Enrollment: 20
Groups/Cohorts
CABG group
Patients undergoing coronary artery bypass graft with cardiopulmonary bypass
OPCAB group
Patients undergoing off-pump coronary artery bypass graft

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Twenty patients undergoing elective coronary artery bypass graft surgery

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622791

Locations
Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Maria M Carmona, MD PhD Faculdade de Medicina da Universidade de São Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria J. C. Carmona, Faculdade de Medicina da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00622791     History of Changes
Other Study ID Numbers: 802-01
Study First Received: February 13, 2008
Last Updated: February 13, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Cardiopulmonary bypass
coronary artery bypass graft
coronary artery disease
propofol
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014