Surgery

General anaesthesia

Anesthesia

Pediatrics

Medicine

Randomized controlled trial

The Lancet

Andrew Davidson and colleagues' GAS trial (Jan 16, p 239)1Davison AJ Disma N de Graaff JC et al.for the GAS consortiumNeurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.Lancet. 2016; 387: 239-250Summary Full Text Full Text PDF PubMed Scopus (596) Google Scholar reports outcomes that are different to those initially registered on ClinicalTrials.gov (NCT00756600). There was one prespecified primary outcome, the Wechsler Preschool and Primary Scale of Intelligence (third edition) Full Scale IQ score, measured at 5 years corrected age, which was not reported; but with clear reasons for this stated in the paper. There were three prespecified secondary outcomes. One of which, the Bayley neurodevelopmental scale, was not clearly defined. The other two, frequency of apnoea and characteristics of apnoea, in the postoperative period and measured at 2 years, were not reported in the paper. Additionally, the paper reports 26 new secondary outcomes that were not prespecified, without declaring them as such. 21 of these non-prespecified outcomes are subtypes of the Bayley score. CH has received grant funding from the WHO and the National Institute for Health Research School of Primary Care Research and is a founder of the AllTrials campaign. ES and HD declare no competing interests. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trialFor this secondary outcome, we found no evidence that just less than 1 h of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at 2 years of age compared with awake-regional anaesthesia. Full-Text PDF The GAS trial – Authors' replyBeverley Orser and colleagues correctly point out the limitations of our study,1 which were also highlighted in our discussion and the accompanying Comment.2 We agree that a more extensive follow-up of the children aged 5 years is essential, that indeed is our primary outcome. We also agree with Markus Weiss and colleagues that there are many other factors besides possible anaesthetic neurotoxic effects that might influence the short-term and long-term outcome of anaesthesia and surgery in infants. Full-Text PDF