The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes. Secondary objectives are to…
ID
Source
Brief title
Condition
- Other condition
- Congenital and peripartum neurological conditions
Synonym
Health condition
anesthesiologie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the WPPSI-III Full Scale IQ score at 5 years
corrected age.
Secondary outcome
1) Other measures of neurodevelopmental outcome
2) Incidence of apnoea
3) Other outcomes relating to anaesthesia group
4) Incidental outcomes not related to choice of anaesthesia
Background summary
Recent animal data has provided evidence to suggest that several commonly used
anaesthetic agents (including volatile anaesthetic agents) may be neurotoxic to
the developing brain.
Study objective
The primary objective of this trial is to determine whether different types of
anaesthesia [regional versus general] given to infants undergoing inguinal
hernia repair result in equivalent neurodevelopmental outcomes. Secondary
objectives are to describe the frequency and characteristics of apnoea in the
post-operative period after both regional and general anaesthesia for inguinal
hernia repair in infants, and determine the factors associated with apnoea.
Study design
Prospective, observer blind, multi-site, randomised, controlled, equivalence
trial.
Intervention
The general anaesthesia group will receive sevoflurane for maintenance and
induction. The airway can be maintained with a face mask, laryngeal mask or
endotracheal tube, with or without neuromuscular blocking agents. Analgesia can
be supplied with a caudal or ilioinguinal nerve block with bupivacaine up to a
maximum dose of 2.5 mg/kg.
The regional group will have no sedative agents. The regional blockade may be
with spinal block alone, spinal block with caudal block, spinal with
ilioinguinal block or caudal alone. A maximum dose of 2.5 mg/kg of bupivacaine
can be used.
Study burden and risks
There is a strong argument to believe equipoise exists in this trial. Awake
regional and general anaesthesia are both accepted standards of care for
inguinal hernia repair in children. Regional anaesthesia may be more
technically demanding and preferences for one or the other may vary depending
on the experience of the paediatric anaesthetist. In younger patients regional
anaesthesia may be associated with less apnoea than general anaesthesia but
this may be less apparent with the newer general anaesthesia agents. Similarly
although there is animal data for toxicity, the evidence for risk of general
anaesthesia is sufficiently weak to accept general anaesthesia as an arm in the
study.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
Any infant whose gestational age (GA) is 26 weeks or more
Any infant whose post-menstrual age (PMA) is up to 60 weeks.
Exclusion criteria
1. Any child older than 60 weeks post-menstrual age
2. Any child born at less than 26 weeks gestation
3. Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)
4. Pre-operative ventilation immediately prior to surgery
5. Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy
6. Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
7. Children where follow-up would be difficult for geographic or social reasons
8. Families where Dutch is not the language spoken at home
9. Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra-ventricular haemorrhage (IVH) (+/- post-haemorrhage ventricular dilatation)
10. Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero
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 | EUCTR2006-006295-37-NL |
| ISRCTN | ISRCTN12437565 |
| CCMO | NL32531.041.10 |