A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants (GAS)
|Inguinal Hernia||Drug: Regional Anesthesia Drug: General Anesthesia||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants|
- 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 chronological age ]
- Bayley neurodevelopmental scale. Also, frequency and characteristics of apnea in the post-operative period. [ Time Frame: At 2 years corrected age. ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||January 2018 (Final data collection date for primary outcome measure)|
Active Comparator: 1
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.
Other Name: Spinal Anesthesia.
Active Comparator: 2
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.
Other Name: General Anesthesia.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756600
Show 30 Study Locations
|Principal Investigator:||Andrew Davidson, MD||Royal Children's Hospital, Victoria, Australia|
|Principal Investigator:||Mary Ellen McCann, MD||Children's Hospital Boston, United States of America|
|Principal Investigator:||Neil Morton, MD||Royal Hospital for Sick Children, Glasgow, United Kingdom|