Overview

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:

Participant gender:

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

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