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Sponsors and Collaborators: |
Children's Hospital Boston Royal Children's Hospital Royal Hospital for Sick Children Murdoch Childrens Research Institute Food and Drug Administration (FDA) |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00756600 |
The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 660 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 | Intervention | Phase |
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Inguinal Hernia |
Drug: Regional Anesthesia Drug: General Anesthesia |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study |
Official Title: | A Multi-Site Randomised Controlled Trial Comparing Regional and General Anaesthesia for Effects on Neurodevelopmental Outcome and Apnoea in Infants |
Estimated Enrollment: | 660 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2016 |
Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Regional Anesthesia
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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.
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2: Active Comparator
General Anesthesia
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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.
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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.
Ages Eligible for Study: | 26 Weeks to 60 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrew Davidson, MD | + 61 3 93455233 | andrew.davidson@rch.org.au |
Contact: Suzette Sheppard | + 61 3 93455233 | suzette.sheppard@mcri.edu.au |
United States, Massachusetts | |
Children's Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Mary Ellen McCann mary.mccann@childrens.harvard.edu | |
Contact: Brenda Barton brenda.barton@childrens.harvard.edu | |
Principal Investigator: Mary Ellen McCann | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | Not yet recruiting |
Hanover, New Hampshire, United States, 03755 | |
Contact: Andreas Taenzar, MD 603-650-6823 | |
Principal Investigator: Andreas Taenzar | |
Australia, South Australia | |
Adelaide Women's and Children's Hospital | Recruiting |
North Adelaide, South Australia, Australia, 5006 | |
Contact: David Costi, MD +61 8 8161 7231 | |
Principal Investigator: David Costi | |
Australia, Victoria | |
Royal Children's Hospital | Recruiting |
Parkville, Victoria, Australia, 3052 | |
Contact: Andrew Davidson andrew.davidson@rch.org.au | |
Contact: Suzette Sheppard suzette.sheppard@mcri.edu.au | |
Principal Investigator: Andrew Davidson | |
Monash Medical Centre | Recruiting |
Clayton, Victoria, Australia, 3165 | |
Contact: Mark Fajgman 61 3 9594 3283 | |
Principal Investigator: Mark Fajgman | |
Australia, Western Australia | |
Princess Margaret Hospital | Recruiting |
Perth, Western Australia, Australia, 6008 | |
Contact: Bruce Hullett + 61 3 8 9340 8222 | |
Principal Investigator: Bruce Hullett | |
Canada, Quebec | |
Montreal Children's Hospital | Recruiting |
Montreal, Quebec, Canada, H3H 1P3 | |
Contact: Davinia Withington (514) 412 4400 | |
Principal Investigator: Davinia Withington | |
Italy | |
G. Gaslini Children's Hospital | Recruiting |
Genoa, Italy, 16147 | |
Contact: Nicola Disma +39 010 563 6445 | |
Principal Investigator: Nicola Disma | |
United Kingdom, Glasgow | |
Royal Hospital for Sick Children | Not yet recruiting |
Yorkhill, Glasgow, United Kingdom, G3 8SJ | |
Contact: Neil Morton nsmorton@tiscali.co.uk | |
Principal Investigator: Neil Morton |
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 |
Responsible Party: | Children's Hospital Boston ( Dr. Mary Ellen McCann ) |
Study ID Numbers: | 06-07-0320 |
Study First Received: | September 18, 2008 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00756600 History of Changes |
Health Authority: | United States: Institutional Review Board; Australia: Human Research Ethics Committee; United Kingdom: Research Ethics Committee; Italy: Ethics Committee; Canada: Ethics Review Committee |
Infants scheduled unilateral bilateral repair |
Pathological Conditions, Anatomical Apnea Hernia Hernia, Abdominal Central Nervous System Depressants |
Anesthetics Bupivacaine Hernia, Inguinal Anesthetics, Local Sevoflurane |
Pathological Conditions, Anatomical Therapeutic Uses Hernia Physiological Effects of Drugs Hernia, Abdominal |
Central Nervous System Depressants Anesthetics Hernia, Inguinal Central Nervous System Agents Pharmacologic Actions |