A multi-site randomised controlled trial comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants

Phase 4

Completed

• Conditions: Infant scheduled for unilateral or bilateral inguinal hernia repair; Anaesthesiology - Other anaesthesiology; Surgery - Other surgery; Neurological - Other neurological disorders

• Registration Number: ACTRN12606000441516
• Lead Sponsor: Professor Andrew Davidson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

* Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision) * Any infant whose gestational age is 26 weeks or more (GA = 182 days)* Any infant whose post-menstrual age is up to 60 weeks (PMA = 426 days)

Exclusion Criteria

* Any child older than 60 weeks post menstrual age * Any child born at less than 26 weeks gestation * Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)* Pre-operative ventilation immediately prior to surgery* Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy* Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development* Children where follow-up would be difficult for geographic or social reasons* Families where English (or French for Paris and Montreal sites) is not the language spoken at home* Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular haemorrhage (IVH) (+/- post haemorrhage ventricular dilatation)* Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence - Third Edition (WPPSI-III) full Scale IQ score. This scale will be used to determine whether different types of anaesthesia (Regional vs General) given to infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes.[At 5 years chronological age]