To evaluate the influence of DSA monitoring, provided by the NarcotrendTM monitor, on the speed of emergence and recovery from GA.
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the influence of density spectral array monitoring with the Narcotrend monitor
on the speed of emergence from general anaesthesia with sevoflurane. The speed
of emergence is defined as the time interval between the end of hypnotic drug
application and the moment when discharge criteria from the operating room are
met (defined as a Steward score >= 3).
Secondary outcome
Total time from discontinuation of anaesthetic drug delivery until discharge
from the post anaesthesia care unit.
The difference in intra-operative blood pressure between the intervention group
and the control group.
Differences of depth of hypnosis during the procedure, as measured by the
Narcotrend monitorTM.
The incidence of postoperative delirium by the Cornell Assessment of
Postoperative Delirium (CAPD) score
Incidence of recall of events during the procedure (awareness)
Adverse events
Background summary
Electroencephalographic density spectral array (DSA) is a three dimensional
method to display electroencephalogram (EEG) signals consisting of the EEG
frequency (y-axis), the power of the EEG signal (colour-coded to be integrated
into a two dimensional plot) and the development of the EEG power spectrum over
time (x-axis). DSA is routinely used to measure depth of hypnosis (DoH) by a
part of the staff members in our department. When DSA is used, dose adjustments
of sevoflurane will be made based on monitoring depth of anaesthesia. However,
most of our colleague do not use DSA. Dose adjustment is then based on
(subjective) clinical surrogate parameters, or in general mostly based on a
minimal alveolar concentration of the anaesthetic gas that is used.
Electroencephalographic DSA monitoring provides continuous objective
information on DoH and should result in a faster speed of emergence and
recovery from general anaesthesia (GA). This will be addressed in a randomised
controlled trial.
Study objective
To evaluate the influence of DSA monitoring, provided by the NarcotrendTM
monitor, on the speed of emergence and recovery from GA.
Study design
Single centre, prospective randomised, double-blind, controlled trial.
Intervention
In patients randomised to the intervention group of the trial, the anaesthetic
agent sevoflurane will be titrated according to the typical DSA pattern for GA
with sevoflurane, provided by the NarcotrendTM.
In patients randomised to the control group, sevoflurane will be titrated
according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end
tidal sevoflurane concentration of 2.3% based on standard practice in our
paediatric anaesthesia department.
Study burden and risks
In patients randomised to the intervention group, the anaesthetic agent
sevoflurane will be administered on the basis of objective measures of
anaesthetic depth, the typical DSA pattern for GA. We expect a significantly
faster speed of emergence and recovery based on clinical experiences with the
use of DSA. The NarcotrendTM monitor is validated for use in paediatric
patients. There are thus no additional risk factors apart from those, which are
inherent with general anaesthesia. Patient randomised to the control group will
receive standard treatment, that is delivery of sevoflurane based on a MAC of
0.9 respectively an end tidal sevoflurane concentration of 2.3%.
A non-invasive therapeutical intervention (DSA based conduct of GA) should
result in the advantage of faster recovery, without any additional risk
factor.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Written informed consent of the parents/legal representatives
Age > 6 months and < 12 years
Surgical procedure requiring general anaesthesia supplemented with caudal
analgesia
Ability of the parents or legal guardians to communicate in Dutch
Exclusion criteria
Withdrawal of informed consent
(Chronic) use of drugs influencing the electroencephalogram
Use of premedication
Known intolerance for sevoflurane
Parents/legal guardians unable to communicate in Dutch
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 |
|---|---|
| CCMO | NL80282.078.22 |