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

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ClinicalTrials.gov Identifier: NCT00756600
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
Royal Children's Hospital
Royal Hospital for Sick Children
Murdoch Childrens Research Institute
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Mary Ellen McCann, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: Regional Anesthesia Drug: General Anesthesia Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
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
Actual Study Start Date : October 23, 2006
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: 1
Regional Anesthesia
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
General Anesthesia
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.




Primary Outcome Measures :
  1. 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 ]
    Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability.


Secondary Outcome Measures :
  1. Composite/domain scores of the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III) [ Time Frame: At 5 years corrected age. ]
    Specifically; Verbal IQ, Performance IQ, Processing Speed Quotient

  2. Selected Developmental Neuropsychological Assessment second edition (NEPSY-II) sub tests to assess other cognitive skills [ Time Frame: At 5 years chronological age ]
    Specifically; Sentence Repetition scaled score, Auditory Attention combined scaled score, Inhibition combined scaled score, Statue scaled score, Word Generation Scaled score, Word Generation scaled score, Speeded Naming combined scaled score, Memory for Names and Memory for Names Delay, Affect Recognition scaled score, Theory of Mind scaled score, Fingertip tapping repetitions scaled score and sequences scaled score, and Design Copy Process Total Scaled Score

  3. Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child [ Time Frame: At 5 years chronological age ]
    Specifically; Word Reading standard score, Numerical Operations standard score, Spelling standard score

  4. Children's Memory Scale (CMS) [ Time Frame: At 5 years chronological age ]
    Specifically; Numbers Total scaled score, Word Lists 1 (learning) scaled score, Memory and learning Word Lists II (delayed) scaled score

  5. Parent/caregiver rated scales to assess the behavior of the children. [ Time Frame: At 5 years chronological age ]

    The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function - Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities.

    The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System - 2nd edition (ABAS-II) to measure the child's adaptive behavior.

    The Total Problems Score of the Child Behaviour Checklist Caregiver Questionnaire (CBCL) to measure behavioural problems consisting of the Total Problems Score, CBCL internalising problems T score and CBCL externalising problems T score


  6. Developmental Issues [ 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.

  7. Developmental Issues [ 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.

  8. Developmental Issues [ 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.

  9. Behavioural disorders [ 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.

  10. Behavioural disorders [ 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.

  11. Behavioural disorders [ Time Frame: At 5 years chronological age ]
    Child has been diagnosed with Oppositional Defiant Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.

  12. Physical disability [ 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.

  13. Physical disability [ 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.

  14. Physical disability [ 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.

  15. Physical disability [ 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.

  16. Physical disability [ 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.

  17. 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.

  18. Awareness of group allocation by Psychologist/Pediatrician [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756600


  Show 30 Study Locations
Sponsors and Collaborators
Boston Children’s Hospital
Royal Children's Hospital
Royal Hospital for Sick Children
Murdoch Childrens Research Institute
Food and Drug Administration (FDA)
Investigators
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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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary Ellen McCann, MD, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT00756600     History of Changes
Other Study ID Numbers: 06-07-0320
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mary Ellen McCann, Boston Children’s Hospital:
Infants
scheduled
unilateral
bilateral
repair
Additional relevant MeSH terms:
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Hernia, Inguinal
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs