A multi-site RCT comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants. - The GAS Study

Phase 1

• Conditions: Inguinal hernia in neonates and infants; MedDRA version: 8.1Level: PTClassification code 10022016Term: Inguinal hernia

• Registration Number: EUCTR2006-006295-37-GB
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-29
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

Any child scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 the primary language spoken at home is not the language in which the WPSI-III will be given [i.e. English for Australian sites, French for Paris site and English or Spanish for US sites]
•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 clinical trial of medicinal product
• Study Design: Not specified