Inguinal HerniaPhase 4GASNCT00756600
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
A Phase 4 study testing Regional Anesthesia and General Anesthesia in people with Inguinal Hernia, run by Boston Children's Hospital at 30 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 60 weeks
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Regional Anesthesia and General Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 30 sitesin 7 countries
- Study dates
- 23 Oct 2006to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
United States10 sites
The Children's Hospital Denver
Aurora, Colorado, 80045
Children's Hospital Boston
Boston, Massachusetts, 02115
Vermont Children's Hospital at Fletcher Allen Health Care
Burlington, Vermont, 05401
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Medical Center of Dallas
Dallas, Texas, 75235
The University of Iowa Hospital
Iowa City, Iowa, 52242
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Vanderbilt Children's Hospital
Nashville, Tennessee, 37212
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's Hospital
Seattle, Washington, 98105
Australia6 sites
Casey Hospital
Berwick, Victoria, 3806
Monash Medical Centre
Clayton, Victoria, 3165
Cabrini Hospital
Malvern, Victoria, 3144
Adelaide Women's and Children's Hospital
North Adelaide, South Australia, 5006
Royal Children's Hospital
Parkville, Victoria, 3052
Princess Margaret Hospital
Perth, Western Australia, 6008
United Kingdom6 sites
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BE
Birmingham Children's Hospital
Birmingham, B4 6NH
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
Royal Hospital for Sick Children
Glasgow, G3 8SJ
Royal Liverpool Children's Hospital
Liverpool, L12 2APS
Sheffield Children's Hospital
Sheffield, S10 2TS
Italy3 sites
Ospedali Riuniti Di Bergamo
Bergamo, 24100
G. Gaslini Children's Hospital
Genoa, 16147
'Vitore Buzzi' Children's Hospital
Milan, 20100
Canada2 sites
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
Netherlands2 sites
Universitair Medisch Centrum Groningen
Groningen, 9700 RB
Wilhelmina Children's Hospital; University Medical Centre Utrecht
Utrecht
About this study
Official title: A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea 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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Regional Anesthesia, General Anesthesia
- Keywords
- Infants, scheduled, unilateral, bilateral, repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaDrug
Also called Spinal 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.
General AnesthesiaDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Regional Anesthesia Receives: Drug: Regional Anesthesia |
| 2 | Active comparator | General Anesthesia Receives: Drug: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Scale IQ Score
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.
Measured: At 5 years chronological age
Secondary outcomes (39)
Verbal IQ
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.
Measured: At 5 years corrected age.
Performance IQ
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.
Measured: At 5 years corrected age
Processing Speed Quotient
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.
Measured: At 5 years corrected age
Sentence Repetition Scaled Score
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.
Measured: At 5 years chronological age
Auditory Attention Combined Scaled Score
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.
Measured: At 5 years corrected age
Statue Scaled Score
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.
Measured: At 5 years corrected age
Inhibition Combined Scaled Score
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.
Measured: At 5 years corrected age
Word Generation Scaled Score
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.
Measured: At 5 years corrected age
Affect Recognition Scaled Score
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.
Measured: At 5 years corrected age
Memory for Names and Memory for Names Delay
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.
Measured: At 5 years corrected age
Theory of Mind Scaled Score
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.
Measured: At 5 years corrected age
Speeded Naming Combined Scaled Score
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.
Measured: At 5 years corrected age
Fingertip Tapping Repetitions Scaled Score
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.
Measured: At 5 years corrected age
Fingertip Tapping Sequences Scaled Score
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.
Measured: At 5 years corrected age
Design Copy Process Total Scaled Score
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.
Measured: At 5 years corrected age
Word Reading Standard Score
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.
Measured: At 5 years chronological age
Numerical Operations Standard Score
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.
Measured: At 5 years chronological age
Spelling Standard Score
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.
Measured: At 5 years chronological age
Numbers Total Scaled Score
Children's Memory Scale (CMS):Numbers Total scaled score
Minimum possible score: 1 Maximum possible score: 19
A higher score indicates a better outcome.
Measured: At 5 years chronological age
Word Lists 1 (Learning) Scaled Score
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.
Measured: At 5 years chronological age
Memory and Learning Word Lists II (Delayed) Scaled Score
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.
Measured: At 5 years chronological age
The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
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.
Measured: At 5 years chronological age
The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
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.
Measured: At 5 years chronological age
Total Problems Score
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.
Measured: At 5 years chronological age
Internalising Problems T Score
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.
Measured: At 5 years chronological age
Externalising Problems T Score
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.
Measured: At 5 years chronological age
Speech or Language Interventions
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.
Measured: At 5 years chronological age
Psychomotor Interventions
Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Measured: At 5 years chronological age
Number of Participants With Global Developmental Delay
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.
Measured: At 5 years chronological age
Number of Participants With Attention Deficit Hyperactivity Disorder
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.
Measured: At 5 years chronological age
Number of Participants With Autism Spectrum Disorder
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.
Measured: At 5 years chronological age
Number of Participants With a Hearing Abnormality
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.
Measured: At 5 years chronological age
Number of Participants With a Visual Defect in Either Eye
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.
Measured: At 5 years chronological age
Number of Participants With a Hearing Aid
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.
Measured: At 5 years chronological age
Number of Participants Who Are Legally Blind
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.
Measured: At 5 years chronological age
Number of Participants Who Have Cerebral Palsy
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.
Measured: At 5 years chronological age
Parents' Awareness of Group Allocation
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.
Measured: At 5 years chronological age
Awareness of Group Allocation by Psychologist
These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Measured: At 5 years chronological age
Awareness of Group Allocation by Pediatrician
Measured: At 5 years chronological age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study start23 Oct 2006
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital for Sick Children, Murdoch Childrens Research Institute, Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Mary Ellen McCann, Boston Children's Hospital
- Investigators
- Andrew Davidson, MD, Principal investigator, Royal Children's Hospital, Victoria, AustraliaMary Ellen McCann, MD, Principal investigator, Children's Hospital Boston, United States of AmericaNeil Morton, MD, Principal investigator, Royal Hospital for Sick Children, Glasgow, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756600
- Sponsor's protocol ID
- 06-07-0320
- Acronym
- GAS
- Status last verified
- Apr 2020
- First submitted
- 18 Sep 2008
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Davidson A, McCann ME, Morton N. Anesthesia neurotoxicity in neonates: the need for clinical research. Anesth Analg. 2007 Sep;105(3):881-2. doi: 10.1213/01.ane.0000269692.57331.48. No abstract available.
PubMed 17717261McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
PubMed 30782342Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.
PubMed 26507180
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants
- ClinicalTrials.gov ID
- NCT00756600
- Acronym / sponsor ID
- GAS / 06-07-0320
- Conditions
- Inguinal Hernia
- Keywords
- Infants, scheduled, unilateral, bilateral, repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Royal Children's Hospital, Royal Hospital for Sick Children, Murdoch Childrens Research Institute, Food and Drug Administration (FDA)
- Study start
- 23 Oct 2006 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Regional AnesthesiaRegional Anesthesia |
| 2 | Active comparator | Drug: General AnesthesiaGeneral Anesthesia |
Who may qualify
- Ages
- Up to 60 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional AnesthesiaAlso: Spinal 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. | Drug | 1 |
| General AnesthesiaAlso: 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. | Drug | 2 |
Primary outcome
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.
39 secondary outcomes
Verbal IQ
Time frame: At 5 years corrected age.
Performance IQ
Time frame: At 5 years corrected age
Processing Speed Quotient
Time frame: At 5 years corrected age
Sentence Repetition Scaled Score
Time frame: At 5 years chronological age
Auditory Attention Combined Scaled Score
Time frame: At 5 years corrected age
Statue Scaled Score
Time frame: At 5 years corrected age
Inhibition Combined Scaled Score
Time frame: At 5 years corrected age
Word Generation Scaled Score
Time frame: At 5 years corrected age
Affect Recognition Scaled Score
Time frame: At 5 years corrected age
Memory for Names and Memory for Names Delay
Time frame: At 5 years corrected age
Theory of Mind Scaled Score
Time frame: At 5 years corrected age
Speeded Naming Combined Scaled Score
Time frame: At 5 years corrected age
Fingertip Tapping Repetitions Scaled Score
Time frame: At 5 years corrected age
Fingertip Tapping Sequences Scaled Score
Time frame: At 5 years corrected age
Design Copy Process Total Scaled Score
Time frame: At 5 years corrected age
Word Reading Standard Score
Time frame: At 5 years chronological age
Numerical Operations Standard Score
Time frame: At 5 years chronological age
Spelling Standard Score
Time frame: At 5 years chronological age
Numbers Total Scaled Score
Time frame: At 5 years chronological age
Word Lists 1 (Learning) Scaled Score
Time frame: At 5 years chronological age
Memory and Learning Word Lists II (Delayed) Scaled Score
Time frame: At 5 years chronological age
The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
Time frame: At 5 years chronological age
The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
Time frame: At 5 years chronological age
Total Problems Score
Time frame: At 5 years chronological age
Internalising Problems T Score
Time frame: At 5 years chronological age
Externalising Problems T Score
Time frame: At 5 years chronological age
Speech or Language Interventions
Time frame: At 5 years chronological age
Psychomotor Interventions
Time frame: At 5 years chronological age
Number of Participants With Global Developmental Delay
Time frame: At 5 years chronological age
Number of Participants With Attention Deficit Hyperactivity Disorder
Time frame: At 5 years chronological age
Number of Participants With Autism Spectrum Disorder
Time frame: At 5 years chronological age
Number of Participants With a Hearing Abnormality
Time frame: At 5 years chronological age
Number of Participants With a Visual Defect in Either Eye
Time frame: At 5 years chronological age
Number of Participants With a Hearing Aid
Time frame: At 5 years chronological age
Number of Participants Who Are Legally Blind
Time frame: At 5 years chronological age
Number of Participants Who Have Cerebral Palsy
Time frame: At 5 years chronological age
Parents' Awareness of Group Allocation
Time frame: At 5 years chronological age
Awareness of Group Allocation by Psychologist
Time frame: At 5 years chronological age
Awareness of Group Allocation by Pediatrician
Time frame: At 5 years chronological age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17717261Davidson A, McCann ME, Morton N. Anesthesia neurotoxicity in neonates: the need for clinical research. Anesth Analg. 2007 Sep;105(3):881-2. doi: 10.1213/01.ane.0000269692.57331.48. No abstract available.
- Derived from this study: PubMed 30782342McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.
- Derived from this study: PubMed 26507180Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Davidson, MD principal investigator
Royal Children's Hospital, Victoria, Australia
Mary Ellen McCann, MD principal investigator
Children's Hospital Boston, United States of America
Neil Morton, MD principal investigator
Royal Hospital for Sick Children, Glasgow, United Kingdom
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Regional Anesthesia and General Anesthesia in people with Inguinal Hernia, run by Boston Children's Hospital at 30 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Australia, United Kingdom, Italy, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Scale IQ Score (time frame: At 5 years chronological age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00756600, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020; AzTrials last refreshed its copy on 27 Oct 2026.