A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants
Overview
- Phase
- Phase 4
- Intervention
- Regional Anesthesia
- Conditions
- Inguinal Hernia
- Sponsor
- Boston Children's Hospital
- Enrollment
- 643
- Locations
- 30
- Primary Endpoint
- Full Scale IQ Score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Mary Ellen McCann
MD
Boston Children's Hospital
Eligibility Criteria
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.
Arms & Interventions
1
Regional Anesthesia
Intervention: Regional Anesthesia
2
General Anesthesia
Intervention: General Anesthesia
Outcomes
Primary Outcomes
Full Scale IQ Score
Time Frame: At 5 years chronological age
The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability. Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Secondary Outcomes
- Verbal IQ(At 5 years corrected age.)
- Processing Speed Quotient(At 5 years corrected age)
- Sentence Repetition Scaled Score(At 5 years chronological age)
- Auditory Attention Combined Scaled Score(At 5 years corrected age)
- Statue Scaled Score(At 5 years corrected age)
- Affect Recognition Scaled Score(At 5 years corrected age)
- Memory for Names and Memory for Names Delay(At 5 years corrected age)
- Inhibition Combined Scaled Score(At 5 years corrected age)
- Theory of Mind Scaled Score(At 5 years corrected age)
- Speeded Naming Combined Scaled Score(At 5 years corrected age)
- Fingertip Tapping Repetitions Scaled Score(At 5 years corrected age)
- Fingertip Tapping Sequences Scaled Score(At 5 years corrected age)
- Design Copy Process Total Scaled Score(At 5 years corrected age)
- Performance IQ(At 5 years corrected age)
- Word Generation Scaled Score(At 5 years corrected age)
- Numerical Operations Standard Score(At 5 years chronological age)
- Spelling Standard Score(At 5 years chronological age)
- Numbers Total Scaled Score(At 5 years chronological age)
- Word Lists 1 (Learning) Scaled Score(At 5 years chronological age)
- Memory and Learning Word Lists II (Delayed) Scaled Score(At 5 years chronological age)
- The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function(At 5 years chronological age)
- Word Reading Standard Score(At 5 years chronological age)
- The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System(At 5 years chronological age)
- Total Problems Score(At 5 years chronological age)
- Internalising Problems T Score(At 5 years chronological age)
- Externalising Problems T Score(At 5 years chronological age)
- Speech or Language Interventions(At 5 years chronological age)
- Psychomotor Interventions(At 5 years chronological age)
- Number of Participants With Global Developmental Delay(At 5 years chronological age)
- Number of Participants With Attention Deficit Hyperactivity Disorder(At 5 years chronological age)
- Number of Participants With Autism Spectrum Disorder(At 5 years chronological age)
- Number of Participants With a Hearing Abnormality(At 5 years chronological age)
- Number of Participants With a Visual Defect in Either Eye(At 5 years chronological age)
- Number of Participants With a Hearing Aid(At 5 years chronological age)
- Number of Participants Who Are Legally Blind(At 5 years chronological age)
- Number of Participants Who Have Cerebral Palsy(At 5 years chronological age)
- Parents' Awareness of Group Allocation(At 5 years chronological age)
- Awareness of Group Allocation by Psychologist(At 5 years chronological age)
- Awareness of Group Allocation by Pediatrician(At 5 years chronological age)