Inguinal Hernia Clinical Trial
Official title:
A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants
The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.
This is a prospective, observer blind, multi-site, randomized, controlled, equivalence trial.
The general anesthesia group will receive sevoflurane (intervention drug) for induction and
maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus
bupivacaine local anesthetic blockade (up to 2.5 mg per kg) administered via caudal or
ilioinguinal nerve block. The airway can be maintained with a face mask, laryngeal mask or
endotracheal tube, with or without neuromuscular blocking agents.
The regional group will have no sedative agent. The regional blockade may be with spinal
alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. The
maximum dose of 2.5 mg per kg of bupivacaine can be used.
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