A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborators: Food and Drug Administration (FDA); Murdoch Childrens Research Institute; Royal Children's Hospital; Royal Hospital for Sick Children
• Treatments: Anesthetics

Criteria

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 less than 26 weeks gestation

• Any contraindication to general or spinal/caudal anesthesia (for example:

neuromuscular disorder or coagulopathy)

• Pre-operative ventilation immediately prior to surgery

• Congenital heart disease that has required 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 is not the primary language spoken at home

• Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular hemorrhage (ICH) (+/- post hemorrhage ventricular dilation)

• Previous exposure to volatile anesthesia or benzodiazepines as a neonate or in the third trimester in utero.