The effects of anaesthesia on neurodevelopmental outcome and apnoea in infants: the GAS study

Not Applicable

Completed

• Conditions: Anaesthesia for unilateral or bilateral inguinal hernia repair; Digestive System; Inguinal hernia

• Registration Number: ISRCTN12437565
• Lead Sponsor: HS Greater Glasgow and Clyde and University of Glasgow (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-03
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

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

Minimum age: 26 weeks
Maximum age: 60 weeks
Gender: both males and females

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 English (or French for Paris and Montreal sites) 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wechsler Pre-school and Primary Scale of Intelligence - Third Edition (WPPSI-III) full scale intelligence quotient (IQ) score. This scale will be used to determine whether different types of anaesthesia (regional versus general) given to infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes at 5 years corrected age.

Secondary Outcome Measures

Name	Time	Method
1. Bayley neurodevelopmental scale at 2 years corrected age<br>2. Heart rate, respiration and oxygen saturation post-anaesthesia in order to measure the frequency and characteristics of apnoea in the post-operative period after both regional and general anaesthesia for inguinal hernia repair in infants for up to 12 hours post-anaesthesia