Propofol Pharmacokinetics and Pharmacodynamics During Car... | NCT00622791

Studies
Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass

NCT00622791

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Feb 25, 2008Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Coronary Artery Disease
Cardiopulmonary Bypass
Coronary Artery Bypass Graft

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 13, 2008

First Submission Date that Met QC Criteria

Feb 13, 2008

First Posted Date

Feb 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2008

Last Update Posted Date

Feb 25, 2008Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CABG group		Patients undergoing coronary artery bypass graft with cardiopulmonary bypass
OPCAB group		Patients undergoing off-pump coronary artery bypass graft

Interventions

Not provided

Measure	Description	Time Frame
Propofol pharmacodynamics and pharmacokinetics

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Twenty patients undergoing elective coronary artery bypass graft surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria M Carmona, MD PhD	Faculdade de Medicina da Universidade de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo		São Paulo	São Paulo	05403000	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19330248	Derived	Barbosa RA, Santos SR, White PF, Pereira VA, Silva Filho CR, Malbouisson LM, Carmona MJ. Effects of cardiopulmonary bypass on propofol pharmacokinetics and bispectral index during coronary surgery. Clinics (Sao Paulo). 2009;64(3):215-21. doi: 10.1590/s1807-59322009000300012.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases