NCT00756600

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

A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 643 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 60 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-10-23
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2008-09-22
• Last updated: 2020-04-29
• Results posted: 2020-04-29

Locations

30 sites across 7 countries: United States, Australia, Canada, Italy, Netherlands, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study