A comparison of general anaesthesia versus awake-regional anaesthesia in infancy: an international, multicentre, randomised controlled equivalence trial; the GAS study

Bell G, et al.
Record ID 32010000404
Authors' objectives: It is quite common for up to 10% of babies to need a hernia repair in early life. Pre-term babies are more often surviving and so this operation is becoming more common. Small babies can have this surgery without any sedation or general anaesthetics if the area of the operation is blocked with local anaesthetic, especially if the local anaesthetic is given near to the spinal cord as a spinal or caudal block. This is a very skilled procedure and doesn't always work so general anaesthesia is an alternative. General anaesthesia is known to be very safe but recently, research on animals has suggested that general anaesthetic agents can in some way damage the developing brain and this has caused some parents to question whether their baby should have a general anaesthetic. To try to answer this question we propose to study two groups of babies, one having a general anaesthetic and the other a local anaesthetic and test their development over 5 years. We expect the two groups to develop similarly but will be monitoring for differences between the groups as they develop. The study will be carried out in specialist children's hospitals who are used to both general and local anaesthetic methods and also used to doing careful assessments of development. The main outcome we are testing is the development at age 5 years, but we also plan to do a general assessments of development and physical status at 2 and 5 years. Standard tools will be used to make these measurements. Awake regional and general anaesthesia are both accepted standards of care for inguinal hernia repair in children. Regional anaesthesia may be more technically demanding and preferences for one or the other may vary depending on the experience of the paediatric anaesthetist. In younger patients regional anaesthesia may be associated with less breathing upset than general anaesthesia but this may be less apparent with the newer general anaesthesia agents. Similarly although there is animal data for toxicity, the evidence for risk of general anaesthesia is sufficiently weak to accept general anaesthesia as an arm in the study. When recruiting patients the researcher approaching the patient must first ensure that both treating surgeon and anaesthetist are comfortable with randomisation. All sites will obtain approval from their local Human Research Ethics Committees. In all cases written informed consent will be obtained from parents or guardians. An independent Data Monitoring Committee and a Trial Steering Committee have been established to oversee the trial. The funding package is mainly for the long term follow up assessments by a specialist in child development.
Project Status: Completed
Year Published: 2021
Requestor: NIHR Health Technology Assessment programme
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: England, United Kingdom
MeSH Terms
  • Anesthesia, General
  • Anesthetics, Local
  • Apnea
  • Infant
  • Child, Preschool
  • Hypotension
  • Blood Pressure
  • Infant, Newborn
  • Anesthesia and Analgesia
  • Hernia
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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