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

Boston Children's Hospital

Status and phase

Completed

Phase 4

Conditions

Inguinal Hernia

Treatments

Drug: General Anesthesia

Drug: Regional Anesthesia

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00756600

06-07-0320

Details and patient eligibility

About

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.

Full 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.

Enrollment

643 patients

Sex

All

Ages

Under 60 weeks old

Volunteers

No Healthy Volunteers

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.