CompletedPhase 4ACTRN12606000441516

A multi-site randomised controlled trial comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants

A multi-site randomised controlled trial comparing bupivacaine (regional) anaesthesia versus sevoflurane (general) anaesthesia for effects on neurodevelopmental outcome and apnoea in infants scheduled for unilateral or bilateral inguinal hernia repair

Sponsor

Professor Andrew Davidson

Enrollment

720 participants

Start Date

Feb 9, 2007

Study Type

Interventional

Conditions

Infant scheduled for unilateral or bilateral inguinal hernia repair

Summary

The primary purpose of the GAS study is to determine whether different types of anaesthesia (Spinal Vs General) given to 660 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnoea in the post-operative period after both spinal and general anaesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anaesthesia for human infants.

Eligibility

Sex: Both males and femalesMin Age: 26 WeekssMax Age: 60 Weekss

Plain Language Summary

Simplified for easier understanding

This study compares regional anesthesia (spinal/caudal) with general anesthesia for inguinal hernia repair in infants, looking at effects on brain development and breathing pauses (apnea). Infants born at 26 weeks gestation or later, up to 60 weeks post-menstrual age, who are scheduled for hernia repair can join.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The general anaesthesia group received sevoflurane for induction and maintenance. The airway could be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents. Analgesia can be supplied with a caudal and/or ilioinguinal nerve block with bupivacaine or levo-bupivacaine up to a maximum dose of 2.5 mg/kg. The regional anaesthesia group received no sedative agents. The regional blockade may be with spinal block alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. A maximum dose of 2.5 mg/kg of bupivacaine or levo-bupivacaine can be used.

Locations(6)

Auckland, New Zealand

Scotland, United Kingdom

Massachusetts, United States of America

Quebec, Canada

Netherlands

Italy

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ACTRN12606000441516