A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
This trial is active, not recruiting.
|Treatments||regional anesthesia, general anesthesia|
|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|
|Aurora, CO||The Children's Hospital Denver||no longer recruiting|
|Chicago, IL||Children's Memorial Hospital||no longer recruiting|
|Iowa City, IA||The University of Iowa Hospital||no longer recruiting|
|Boston, MA||Children's Hospital Boston||no longer recruiting|
|Lebanon, NH||Dartmouth-Hitchcock Medical Center||no longer recruiting|
|Philadelphia, PA||Children's Hospital of Philadelphia||no longer recruiting|
|Nashville, TN||Vanderbilt Children's Hospital||no longer recruiting|
|Dallas, TX||Children's Medical Center of Dallas||no longer recruiting|
|Burlington, VT||Vermont Children's Hospital at Fletcher Allen Health Care||no longer recruiting|
|Seattle, WA||Seattle Children's Hospital||no longer recruiting|
|North Adelaide, Australia||Adelaide Women's and Children's Hospital||no longer recruiting|
|Berwick, Australia||Casey Hospital||no longer recruiting|
|Clayton, Australia||Monash Medical Centre||no longer recruiting|
|Malvern, Australia||Cabrini Hospital||no longer recruiting|
|Parkville, Australia||Royal Children's Hospital||no longer recruiting|
|Perth, Australia||Princess Margaret Hospital||no longer recruiting|
|Montreal, Canada||Montreal Children's Hospital||no longer recruiting|
|Montréal, Canada||Centre Hospitalier Universitaire Sainte-Justine||no longer recruiting|
|Bergamo, Italy||Ospedali Riuniti Di Bergamo||no longer recruiting|
|Genoa, Italy||G. Gaslini Children's Hospital||no longer recruiting|
|Milano, Italy||'Vitore Buzzi' Children's Hospital||no longer recruiting|
|Groningen, Netherlands||Universitair Medisch Centrum Groningen||no longer recruiting|
|Utrecht, Netherlands||Wilhelmina Children's Hospital; University Medical Centre Utrecht||no longer recruiting|
|Auckland, New Zealand||Starship Children's Health||no longer recruiting|
|Yorkhill, United Kingdom||Royal Hospital for Sick Children||no longer recruiting|
|Belfast, United Kingdom||Royal Belfast Hospital for Sick Children||no longer recruiting|
|Birmingham, United Kingdom||Birmingham Children's Hospital||no longer recruiting|
|Bristol, United Kingdom||Bristol Royal Hospital for Children||no longer recruiting|
|Liverpool, United Kingdom||Royal Liverpool Children's Hospital||no longer recruiting|
|Sheffield, United Kingdom||Sheffield Children's Hospital||no longer recruiting|
|Endpoint classification||bio-equivalence study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
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
Bayley neurodevelopmental scale. Also, frequency and characteristics of apnea in the post-operative period.
time frame: At 2 years corrected age.
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.
|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.|
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