GAS Study: A multi-site randomised controlled trial comparing regional and general anaesthesia for effects on neurodevelopmental
The University of MelbourneDataset description
This dataset contains de-identified participant level data from the GAS trial, an international, multicentre, randomised controlled equivalence study examining neurodevelopmental outcomes in children exposed to different anaesthetic techniques in infancy. The dataset includes baseline demographic and clinical characteristics, peri-operative and anaesthetic exposure information, and longitudinal neurodevelopmental assessment data collected up to 5 years of age. Data are structured at the individual participant level and support comparison between children who received general anaesthesia and those who received awake regional anaesthesia during infancy. Outcome data include standardised neurodevelopmental and cognitive assessment measures collected at prespecified follow-up time points. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the GAS Trial Steering Committee must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan. DOI: 10.1016/S0140-6736(18)32485-1 External Link DOI: 10.1097/ALN.0000000000000709 DOI: 10.1097/ALN.0000000000000708 DOI: 10.1016/S0140-6736(15)00608-X DOI: 10.1016/S2352-4642(18)30308-0Date Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12606000441516
Funding
Government body, Murdoch Childrens Research Institute
Scientific enquiries
Prof Andrew Davidson
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 h .... Read more
Key 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)
Key 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 prematurit .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 722
Min. age 26 Weeks
Max. age 60 Weeks
Sex Both males and females
Condition category Infant scheduled for unilateral or bilateral inguinal hernia repair
Condition code Anaesthesiology , Surgery , Neurological
Intervention
Intervention code Treatment: Drugs
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 bl .... Read more
Comparison
Control group Active
Comparator treatment is regional anaesthesia (either: spinal block alone, spinal and caudal block, spinal and ilioinguinal block, caudal block alone) with bupivacaine or levo-bupivacaine to be administered by caudal and/or subarachnoid routes at the beginning of the surgical procedure. Spinal dose: 0.2 ml/kg 0.5% bupivacaine or levo-bupivacaine.. Caudal dose: 2.5 mg/kg bupivacaine or levo-bupivacaine. The duration lasts for approximately 90 minutes. Patients are observed for up to 12 hours (if t .... Read more
Outcomes
Outcome: 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.Timepoint: At 5 years chronological age