Determining the effectiveness of commonly used premedicating agents in reducing subclinical stress responses in newborns during intubation.
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract therapeutic procedures
Synonym
Health condition
stress cq pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Skin conductance parameters: peaks / second
Secondary outcome
Derived skin conductance measurements (average peak and rise time)
Heart rate, blood pressure and oxygen saturation
Intubating conditions
Background summary
Internationally there is widespread variation in premedication before
intubation of newborns, term and preterm. In the Isala Clinics Zwolle, The
Netherlands we use morphine and vecuronium.
There are reasons to look for an alternative for morphine and vecuronium. The
pharmacokinetic profile of morphine is unfavourable making it relatively
unsuitable for acute interventions. Neuromuscular blockade with vecuronium does
improve intubating conditions. However, the effect lasts relatively long,
resulting in unwanted higher ventilating pressures.
Propofol is a relatively new anesthetic compound with rapid onset and short
duration of action. It provides deep hypnosis and possibly has some analgetic
effect. Since the RCT by Ghanta et al. (2007) propofol is increasingly used in
neonatology.
Intubation is known as a painful procedure. Until now we do not have
information about analgesia during intubation, since neuromuscular blockade and
deep sedation prevent clinical assessment of pain. Therefore we want to use
skin conductance measurements to gain insight in subclinical stress responses
during the intubation procedure.
Our hypothesis is that despite premedication the stress response is still
present during the intubation procedure.
Study objective
Determining the effectiveness of commonly used premedicating agents in reducing
subclinical stress responses in newborns during intubation.
Study design
Prospective randomized open observational intervention study.
Intervention
not applicable
Study burden and risks
No burdens or risks.
Dokter van Heesweg 2
8025 AB Zwolle
NL
Dokter van Heesweg 2
8025 AB Zwolle
NL
Listed location countries
Age
Inclusion criteria
All newborns requiring endotracheal intubation
Exclusion criteria
Congenital Heart Disease
Hypotension
(Suspected) congenital metabolic disorder
(Suspected) chromosomal disorder
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 | EUCTR2010-021887-13-NL |
CCMO | NL32588.075.10 |