Phase 4
Completed N=643
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
Source: ClinicalTrials.gov NCT00756600 ↗Enrolled (actual)
643
Serious AEs
—
Results posted
Apr 2020
Primary outcomePrimary: Full Scale IQ Score — 100.5; 100.1 score on scale
◆ Published Evidence
Highly cited
1,131citations · ~113 / year
Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.
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.
Linked Publications (2)
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Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.
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Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Full Scale IQ Score |
100.5; 100.1 | — |
| SECONDARY Verbal IQ |
101.8; 100.9 | — |
| SECONDARY Performance IQ |
100.7; 101.2 | — |
| SECONDARY Processing Speed Quotient |
95.8; 96.3 | — |
| SECONDARY Sentence Repetition Scaled Score |
9.7; 9.7 | — |
| SECONDARY Auditory Attention Combined Scaled Score |
9.0; 9.3 | — |
| SECONDARY Statue Scaled Score |
8.8; 8.6 | — |
| SECONDARY Inhibition Combined Scaled Score |
8.3; 8.9 | — |
| SECONDARY Word Generation Scaled Score |
9.4; 9.3 | — |
| SECONDARY Affect Recognition Scaled Score |
10.6; 10.4 | — |
| SECONDARY Memory for Names and Memory for Names Delay |
8.1; 8.1 | — |
| SECONDARY Theory of Mind Scaled Score |
9.8; 9.3 | — |
| SECONDARY Speeded Naming Combined Scaled Score |
9.7; 9.8 | — |
| SECONDARY Fingertip Tapping Repetitions Scaled Score |
9.8; 9.7 | — |
| SECONDARY Fingertip Tapping Sequences Scaled Score |
8.1; 7.7 | — |
| SECONDARY Design Copy Process Total Scaled Score |
9.6; 9.9 | — |
| SECONDARY Word Reading Standard Score |
92.3; 92.8 | — |
| SECONDARY Numerical Operations Standard Score |
98.8; 96.2 | — |
| SECONDARY Spelling Standard Score |
90.1; 90.8 | — |
| SECONDARY Numbers Total Scaled Score |
8.3; 8.1 | — |
| SECONDARY Word Lists 1 (Learning) Scaled Score |
8.3; 8.6 | — |
| SECONDARY Memory and Learning Word Lists II (Delayed) Scaled Score |
9.7; 9.6 | — |
| SECONDARY The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function |
48.4; 51.5 | — |
| SECONDARY The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System |
95.9; 94.1 | — |
| SECONDARY Total Problems Score |
44.6; 46.7 | — |
| SECONDARY Internalising Problems T Score |
46.1; 48.0 | — |
| SECONDARY Externalising Problems T Score |
44.0; 45.8 | — |
| SECONDARY Speech or Language Interventions |
18; 17 | — |
| SECONDARY Psychomotor Interventions |
8; 6 | — |
| SECONDARY Number of Participants With Global Developmental Delay |
2; 0 | — |
| SECONDARY Number of Participants With Attention Deficit Hyperactivity Disorder |
3; 4 | — |
| SECONDARY Number of Participants With Autism Spectrum Disorder |
5; 11 | — |
| SECONDARY Number of Participants With a Hearing Abnormality |
8; 11 | — |
| SECONDARY Number of Participants With a Visual Defect in Either Eye |
21; 31 | — |
| SECONDARY Number of Participants With a Hearing Aid |
0; 3 | — |
| SECONDARY Number of Participants Who Are Legally Blind |
0; 0 | — |
| SECONDARY Number of Participants Who Have Cerebral Palsy |
1; 3 | — |
| SECONDARY Parents' Awareness of Group Allocation |
105; 118 | — |
| SECONDARY Awareness of Group Allocation by Psychologist |
7; 7 | — |
| SECONDARY Awareness of Group Allocation by Pediatrician |
13; 13 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00756600) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.