This trial is active, not recruiting.

Condition inguinal hernia
Treatments regional anesthesia, general anesthesia
Phase phase 4
Sponsor Children's Hospital Boston
Collaborator Royal Children's Hospital
Start date October 2006
End date January 2017
Trial size 720 participants
Trial identifier NCT00756600, 06-07-0320


The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 660 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
Regional Anesthesia
regional anesthesia Spinal 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.
(Active Comparator)
General Anesthesia
general anesthesia 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.

Primary Outcomes

The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III)full scale IQ score.
time frame: At 5 years corrected age

Secondary Outcomes

Bayley neurodevelopmental scale. Also, frequency and characteristics of apnea in the post-operative period.
time frame: At 2 years corrected age.

Eligibility Criteria

Male or female participants up to 60 weeks old.

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.

Additional Information

Official title A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants
Principal investigator Andrew Davidson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.