A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
NCT ID: NCT00756600
Last Updated: 2020-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
643 participants
INTERVENTIONAL
2006-10-23
2018-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Regional Anesthesia
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.
2
General Anesthesia
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
60 Weeks
ALL
No
Sponsors
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Royal Children's Hospital
OTHER
Royal Hospital for Sick Children
OTHER
Murdoch Childrens Research Institute
OTHER
Food and Drug Administration (FDA)
FED
Boston Children's Hospital
OTHER
Responsible Party
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Mary Ellen McCann
MD
Principal Investigators
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Andrew Davidson, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Children's Hospital, Victoria, Australia
Mary Ellen McCann, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Boston, United States of America
Neil Morton, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Hospital for Sick Children, Glasgow, United Kingdom
Locations
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The Children's Hospital Denver
Aurora, Colorado, United States
Children's Memorial Hospital
Chicago, Illinois, United States
The University of Iowa Hospital
Iowa City, Iowa, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Vermont Children's Hospital at Fletcher Allen Health Care
Burlington, Vermont, United States
Seattle Children's Hospital
Seattle, Washington, United States
Adelaide Women's and Children's Hospital
North Adelaide, South Australia, Australia
Casey Hospital
Berwick, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Princess Margaret Hospital
Perth, Western Australia, Australia
Montreal Children's Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Ospedali Riuniti Di Bergamo
Bergamo, , Italy
G. Gaslini Children's Hospital
Genoa, , Italy
'Vitore Buzzi' Children's Hospital
Milan, , Italy
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Wilhelmina Children's Hospital; University Medical Centre Utrecht
Utrecht, , Netherlands
Starship Children's Health
Auckland, , New Zealand
Royal Belfast Hospital for Sick Children
Belfast, , United Kingdom
Birmingham Children's Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Royal Hospital for Sick Children
Glasgow, , United Kingdom
Royal Liverpool Children's Hospital
Liverpool, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Countries
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References
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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.
McCann 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.
Davidson 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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06-07-0320
Identifier Type: -
Identifier Source: org_study_id
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