Search for a relation between the concentration of haloperidol in serum and in liquor in elderly who reached a steady state of haloperidol. Secundairy aim: Cal inter-individual variation in serum and CSF concentrations, at the same dose haloperidol…
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
Synonym
Health condition
farmacokinetiek van een geneesmiddel/antipsychoticum
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
concentration haloperidol in serum and liquor
Farmacogenetic polymorfisms of the cytochroom P450 enzym CYP2D6
Secondary outcome
age, gender, race, smoking, medication use
Background summary
Haloperidol is the first choice antipsychotic drug for the treatment of
delirium or behavioural problems in dementia. In elderly there is a large
variability in effects and side-effects of haloperidol. There is no previous
research which decribes the relation between plasma haloperidol concentration
and liquor haloperidol concentration. Farmacogenetic variation in polymorfisms
of the cytochroom P450 enzym CYP2D6 is a possible explanation for the inter
individual variation in blood levels of haloperidol at the same dose.
Study objective
Search for a relation between the concentration of haloperidol in serum and in
liquor in elderly who reached a steady state of haloperidol. Secundairy aim:
Cal inter-individual variation in serum and CSF concentrations, at the same
dose haloperidol, be explained by polymorfisms in CYP2D6 allels?
Study design
Cross sectional study design
Study burden and risks
The attending physician treats the patients with regular care. To take an extra
tube cerebrospinal fluid with the spinal anaesthesia gives a slightly elevated
risk of post dural puncture headache.
The incidence of post dural puncture headache is 5-15%. It is caused by
excessive loss of cerebrospinal fluid. When a patient sits or stands straight,
the pressure in the head is lower what can cause a headache. Leakage of
cerebrospinal fluid and the headache are not dangerous.
Taking a tube blood gives a risk of a hematoma.
No oral haloperidol on the morning of the surgery does not matter, because
after five days of haloperidol a steady state is reached.
Henri Dunantstraat 1 Den Bosch
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1 Den Bosch
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
age >64 years
elective operation with spinal anesthesia
elevated risk to develop a delirium and prescription of haloperidol during five days pre-operative in a dose of 1mg/dag as regular care
mentally competent
informed consent
Exclusion criteria
none
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL35631.028.11 |