1. To quantify the influence of propofol on the distribution, redistribution and elimination of ketamine and to evaluate the importance of hemodynamic parameters on the pharmacokinetics of ketamine.2. To quantify the influence of ketamine on the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
sedativum op IC na cardiochirurgische ingreep
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Ramsay score
• BIS score
• Cardiac Output (Vigileo)
• Cardiac Index (Vigileo)
• RRsys
• RRdias
• MAP
• CVP
• HR
• SVV
• SVR
• Saturation
Secondary outcome
Concentration of propofol and ketamine from the several blood draws.
Background summary
propofol and ketamine may well be a promising anesthetic combination for
sedation of patients after cardiac surgery (coronary artery bypass grafting
(CABG) and aortic valve surgery) in the ICU. This study aims to evaluate the
interaction between these 2 agents with respect to their pharmacokinetics
(distribution, redistribution and elimination) and pharmacodynamics (sedation,
hemodynamic side effects and attenuation of the inflammatory response) in
patients after cardiac surgery.
Study objective
1. To quantify the influence of propofol on the distribution, redistribution
and elimination of ketamine and to evaluate the importance of hemodynamic
parameters on the pharmacokinetics of ketamine.
2. To quantify the influence of ketamine on the distribution, redistribution
and elimination of propofol and evaluate the importance of hemodynamic
parameters on the pharmacokinetics of propofol.
3. To evaluate the pharmacodynamic interaction between propofol and ketamine
with respect to the sedative and hemodynamic effects during sedation in
patients sedated in the ICU.
Study design
randomised single blind follup study
Intervention
During study A, 21 ICU patients will be sedated using a target controlled
infusion of propofol at one of 3 fixed target propofol concentrations in
addition to a target controlled infusion of S(+) ketamine with a variable
target ketamine concentration to assure adequate sedation to a Ramsay sedation
score of 4. During study B, ICU 21 patients will be sedated using a target
controlled infusion of S(+) ketamine at one of 3 fixed target ketamine
concentrations in addition to a target controlled infusion of propofol with a
variable target propofol concentration to assure adequate sedation to a Ramsay
sedation score of 4. Meanwhile several hemodynamic en neurological parameters
will be recorded and several blood draws will be performed to measure propofol
and ketamine concentrations.
Study burden and risks
No extra risk apart from the standard risk after cardiac surgery and the risk
of drawing a maximum of 150ml of blood during 6 hours in the post-operative
phase.
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Scheduled for ventilation and sedation at the ICU post cardiac surgery.
Aged 18-80 years.
Being able to give written informed consent.
Exclusion criteria
Unable to give written informed consent.
Increased intracranial pressure
Poor ventricular function
Epilepsy
Psychosis
Glaucoma
History of cerebrovascular incident < 1 year
Pregnancy
Documented or suspected soybean protein and/or drug allergy.
Morbid obesity (BMI > 35).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021484-32-NL |
| CCMO | NL32985.058.10 |
| OMON | NL-OMON27257 |