The primary research inquiry being raised concerns anaesthesia related causes:Is it possible that adapting an amount of sevoflurane, from 1 MAC (minimum alveolar concentration) (2,5 vol%) to * MAC (1,25 vol%) in an MRI scan can reduce the frequency…
ID
Source
Brief title
Condition
- Other condition
- Deliria (incl confusion)
Synonym
Health condition
postoperatieve gedragsstoornissen na sevoflurane anesthesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary research question:
Is it possible that adapting the amount of sevoflurane, from 1 MAC (2,5 vol%)
to * MAC (1,25 vol%) in an MRI scan can reduce the frequency and gravity of ED?
Secondary outcome
Secondary research questions:
1.Do the anxiety of the parents (measured by the APAIS), the anxiety of the
child at induction (measured by the m-YPAS) and the behaviour (measured by the
CBCL 11/2-5) constitute a predictive value for the appearance of ED (measured
with the PAED scale)?
2.In case significant ED appears, can this lead to an increase of behavioural
disorders (measured by the PHBQ) at 1 day, 1 week en 2 weeks after
intervention?
Background summary
*Emergence delirium* (ED) is described as a mental disorder during recovery
from general anaesthesia. After the introduction of new inhalation anaesthetics
such as sevoflurane, this phenomenon again gained prominence. The specific
cause is unknown. Anaesthesia, surgery and patient related factors are part of
the possible explanations.
Study objective
The primary research inquiry being raised concerns anaesthesia related causes:
Is it possible that adapting an amount of sevoflurane, from 1 MAC (minimum
alveolar concentration) (2,5 vol%) to * MAC (1,25 vol%) in an MRI scan can
reduce the frequency and gravity of *emergence delirium*?
The secondary research inquiry being raised concerns patient related causes:
Are parents* and children*s anxiety at induction, as well as their behaviour, a
predictive value for the appearance of *ED*?
In case a significant *ED* appears, can this lead to an increase of behavioural
disorders at 1 day, 1 week and 2 weeks after intervention?
Study design
Randomised double-blinded study in 40 children who have to undergo a MRI scan
for diagnostic reasons under general anaesthesia in the Sophia Children*s
Hospital Erasmus MC Rotterdam. After randomisation the children are divided in
two groups (stratification according to age).
Group A sevoflurane 1 MAC (2,5 vol.%)
Group B sevoflurane 0,5 MAC (1,25 vol.%)
Further division in age group
1. >1,5 year old < 4 years old 2 x 10 children
2. >4 years old < 6 years old 2 x 10 children
*
Intervention
randomization into two groups:
Group A sevoflurane 1 MAC (2,5 vol.%)
Group B sevoflurane 0,5 MAC (1,25 vol.%)
Study burden and risks
This research does not lead to an increased risk. The risk is similar to the
one for general anaesthesia. The accompanying parent will be presented with
two short questionnaires (duration maximum 15 min.). On day 1, day 7 en 2 weeks
after the anaesthesia there will be an assessment over the phone concerning the
postoperative behaviour of the child by means of a standard questionnaire.
Dr. Molewaterplein 60
3015 GJ
NL
Dr. Molewaterplein 60
3015 GJ
NL
Listed location countries
Age
Inclusion criteria
age between 1,5-6 years
children scheduled for MRI scan onder general anesthesia
no premedication
ASA status 1-2
parents who speak Dutch
parents present during anesthesia induction
written informed consent
Exclusion criteria
Cognitive or emotional developmental disorder, with exception of attention deficite hyperactivity disorder.
Use of active ingredients which influence the central nervous system (anticonvulsants)
Risk of malignant hyperthermia
Hypersensitivity to sevoflurane or propofol
Need for premedication
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2010-019420-31-NL |
| CCMO | NL32082.000.10 |