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

Conditions

None listed

Brief summary

The primary purpose of the GAS study is to determine whether different types of anaesthesia (Spinal Vs General) given to 660 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnoea in the post-operative period after both spinal and general anaesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anaesthesia for human infants.

McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ, GAS Consortium.

2019-02-14426 citations

10.1016/s0140-6736(18)32485-1

Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.

Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME, GAS consortium.

2015-11-04577 citations

10.1016/s0140-6736(15)00608-x

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

The general anaesthesia group received sevoflurane for induction and maintenance. The airway could be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents. Analgesia can be supplied with a caudal and/or ilioinguinal nerve block with bupivacaine or levo-bupivacaine up to a maximum dose of 2.5 mg/kg. The regional anaesthesia group received no sedative agents. The regional blockade may be with spinal block alone, spinal block with caudal

The general anaesthesia group received sevoflurane for induction and maintenance. The airway could be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents. Analgesia can be supplied with a caudal and/or ilioinguinal nerve block with bupivacaine or levo-bupivacaine up to a maximum dose of 2.5 mg/kg. The regional anaesthesia group received 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 or levo-bupivacaine can be used.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

26 Weeks to 60 Weeks

Healthy volunteers

No

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.

Outcome results