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NCT Number: NCT00756600

A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

Up to 60 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Adelaide Women's and Children's Hospital, North Adelaide, South Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regional Anesthesia

Drug

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 names: Spinal Anesthesia.

General anesthesia

Drug

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 names: General Anesthesia.

Primary outcomes

  1. 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

  1. Verbal IQ

    Time frame: At 5 years corrected age.

    Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ

    Minimum possible score:45 Maximum possible score:145

    A higher score indicates higher verbal IQ (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.

  2. Performance IQ

    Time frame: At 5 years corrected age

    Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ

    Minimum possible score:45 Maximum possible score:145

    A higher score indicates a higher performance IQ (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.

  3. Processing Speed Quotient

    Time frame: At 5 years corrected age

    Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient

    Minimum possible score:45 Maximum possible score:145

    A higher score indicates a 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.

  4. Sentence Repetition Scaled Score

    Time frame: At 5 years chronological age

    Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  5. Auditory Attention Combined Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  6. Statue Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  7. Inhibition Combined Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  8. Word Generation Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  9. Affect Recognition Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  10. Memory for Names and Memory for Names Delay

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  11. Theory of Mind Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  12. Speeded Naming Combined Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  13. Fingertip Tapping Repetitions Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score is indicative of a better outcome.

  14. Fingertip Tapping Sequences Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  15. Design Copy Process Total Scaled Score

    Time frame: At 5 years corrected age

    Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  16. Word Reading Standard Score

    Time frame: At 5 years chronological age

    Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score

    Minimum possible score: 45 Maximum possible score: 145

    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.

    A higher score indicates a better outcome.

  17. Numerical Operations Standard Score

    Time frame: At 5 years chronological age

    Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score

    Minimum possible score: 45 Maximum possible score: 145

    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.

    A higher score indicates a better outcome.

  18. Spelling Standard Score

    Time frame: At 5 years chronological age

    Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score

    Minimum possible score: 45 Maximum possible score: 145

    A higher score indicates a 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.

  19. Numbers Total Scaled Score

    Time frame: At 5 years chronological age

    Children's Memory Scale (CMS):Numbers Total scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  20. Word Lists 1 (Learning) Scaled Score

    Time frame: At 5 years chronological age

    Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  21. Memory and Learning Word Lists II (Delayed) Scaled Score

    Time frame: At 5 years chronological age

    Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score

    Minimum possible score: 1 Maximum possible score: 19

    A higher score indicates a better outcome.

  22. The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function

    Time frame: At 5 years chronological age

    Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function

    Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities.

    Minimum possible score: 40 Maximum possible score: 110

    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.

    A higher score indicates a worse outcome.

  23. The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System

    Time frame: At 5 years chronological age

    Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System

    • 2nd edition (ABAS-II) to measure the child's adaptive behavior.

    Minimum possible score: 45 Maximum possible score: 145

    A higher score indicates a 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.

  24. Total Problems Score

    Time frame: At 5 years chronological age

    Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems

    Minimum possible score: 40 Maximum possible score: 100

    A higher score indicates a worse 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.

  25. Internalising Problems T Score

    Time frame: At 5 years chronological age

    Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score

    Minimum possible score: 40 Maximum possible score: 100

    A higher score indicates a worse 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.

  26. Externalising Problems T Score

    Time frame: At 5 years chronological age

    Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score

    Minimum possible score: 40 Maximum possible score: 100

    A higher score indicates a worse 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.

  27. Speech or Language Interventions

    Time frame: At 5 years chronological age

    Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  28. Psychomotor Interventions

    Time frame: At 5 years chronological age

    Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  29. Number of Participants With Global Developmental Delay

    Time frame: At 5 years chronological age

    Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  30. Number of Participants With Attention Deficit Hyperactivity Disorder

    Time frame: At 5 years chronological age

    Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  31. Number of Participants With Autism Spectrum Disorder

    Time frame: At 5 years chronological age

    Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  32. Number of Participants With a Hearing Abnormality

    Time frame: At 5 years chronological age

    Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  33. Number of Participants With a Visual Defect in Either Eye

    Time frame: At 5 years chronological age

    Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  34. Number of Participants With a Hearing Aid

    Time frame: At 5 years chronological age

    Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  35. Number of Participants Who Are Legally Blind

    Time frame: At 5 years chronological age

    Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  36. Number of Participants Who Have Cerebral Palsy

    Time frame: At 5 years chronological age

    Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  37. Parents' Awareness of Group Allocation

    Time frame: At 5 years chronological age

    Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  38. Awareness of Group Allocation by Psychologist

    Time frame: At 5 years chronological age

    These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  39. Awareness of Group Allocation by Pediatrician

    Time frame: At 5 years chronological age

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Food and Drug Administration (FDA)
  • Murdoch Childrens Research Institute
  • Royal Children's Hospital
  • Royal Hospital for Sick Children

Registry information

Official study title

A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants

Acronym: GAS

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2008
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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