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

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.

Conditions

• Inguinal Hernia

Interventions

DRUG

Regional Anesthesia

Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.

DRUG

General Anesthesia

Sevoflurane 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/kg) administered via caudal or ilioinguinal nerve block.

Sponsors & Collaborators

• Royal Children's Hospital

  collaborator OTHER

• Royal Hospital for Sick Children

  collaborator OTHER

• Murdoch Childrens Research Institute

  collaborator OTHER

• Food and Drug Administration (FDA)

  collaborator FED

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Andrew Davidson, MD · Royal Children's Hospital, Victoria, Australia

• Mary Ellen McCann, MD · Children's Hospital Boston, United States of America

• Neil Morton, MD · Royal Hospital for Sick Children, Glasgow, United Kingdom

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

60 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-23

Primary Completion

2018-06-30

Completion

2018-06-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Italy
• Netherlands
• New Zealand
• United Kingdom

Study Locations