Primary objective: To investigate the impact of general anaesthesia on cerebral function parameters (regional haemoglobin oxygen saturation, and EEG-patterns). Secondary objectives: To compare cerebral function parameters recorded before and after…
ID
Source
Brief title
NEONART+1
Condition
- Other condition
Synonym
Health condition
onderzoek na hersenfunctie peroperatief bij pasgeboren kinderen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Impact of general anaesthesia on cerebral (and peripheral tissue) regional
oxygen saturation, recorded as quantified variables. Comparison of those
variables under anaesthetised conditions with data recorded before and after
the surgical procedure (non-anaesthetised conditions). Analysis of the EEG in
order to describe potential typical patterns under anaesthetised conditions,
focusing on density spectral array and amplitude integrated EEG.
Secondary outcome
-
Background summary
Little is known about the overall effects of general anaesthesia on the brain
in human neonates and infants. In neonates anaesthetic agents, following a
dose-dependent pattern, significantly lower mean arterial blood pressure (mBP),
with the risk of cerebral hypoperfusion. Furthermore the EEG in neonates is
fundamentally different from older children or adults. In a pilot study in 20
surgical neonates, receiving routine anaesthesia according to good clinical
practice and departmental standards, we investigate the cerebral function
parameters regional cerebral oxygen saturation (+ regional oxygen saturaion of
peripheral tissue) and EEG during the perioperative period. These parameters
will also be linked to mBP and end-tidal CO2. This study is part of our
Neonatal Anaesthesia Related Toxicity project NEONART+ , a huge research
project on safety aspects of anaesthesia in young children.
Study objective
Primary objective: To investigate the impact of general anaesthesia on cerebral
function parameters (regional haemoglobin oxygen saturation, and
EEG-patterns). Secondary objectives: To compare cerebral function parameters
recorded before and after the anaesthestic/surgical procedure with those
recorded under anaesthesia conditions.
Study design
Single centre, prospective observational pilot study
Study burden and risks
This observational pilot study investigates the direct effects of general
anaesthesia on cerebral function parameters in human neonates, together with
the subsequent impact of hemodynamics on these parameters. Enhanced
non-invasive cerebral monitoring is applied in order to determine the most
relevant parameter(s) to describe anaesthetic drug effects on the neonatal
brain. Being an observational study during the perioperative course of a
surgical procedure under general anaesthesia we don*t expect any adverse
reactions other than those always potentially associated with general
anaesthesia and neonatal (emergency) surgery.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
* Postnatal age * 4 weeks
* Surgery under general anaesthesia
* Written informed parental consent
Exclusion criteria
* Contraindications for the use of inhalation anaesthetics
* Preoperative invasive ventilatory support
* Anticipated difficult airway
* Thoracoscopic- or cardiac surgery
* surgical procedures resulting in limited acces to the head for the anaesthetist (i.e. ENT- surgery)
* No written informed parental consent
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 | NL52463.078.15 |