A Multi-Site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants - Full Text View

Sponsors and Collaborators:	Children's Hospital Boston Royal Children's Hospital Royal Hospital for Sick Children Murdoch Childrens Research Institute
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00756600

Purpose

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
Inguinal Hernia	Drug: Regional Anesthesia Drug: General Anesthesia	Phase IV

MedlinePlus related topics: Anesthesia Gas Hernia

U.S. FDA Resources

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

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

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 corrected age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bayley neurodevelopmental scale. Also, frequency and characteristics of apnea in the post-operative period. [ Time Frame: At 2 years corrected age. ] [ Designated as safety issue: No ]

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
1: Active Comparator 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	26 Weeks to 60 Weeks
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756600

Contacts

Contact: Andrew Davidson, MD	+ 61 3 93455233	andrew.davidson@rch.org.au
Contact: Suzette Sheppard	+ 61 3 93455233	suzette.sheppard@mcri.edu.au

Locations

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
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Charles Cote, MD 617-726-2000
Principal Investigator: Charles Cote
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

Sponsors and Collaborators

Children's Hospital Boston

Royal Children's Hospital

Royal Hospital for Sick Children

Murdoch Childrens Research Institute

Investigators

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

More Information

Publications:

Davidson A, McCann ME, Morton N. Anesthesia neurotoxicity in neonates: the need for clinical research. Anesth Analg. 2007 Sep;105(3):881-2. No abstract available.

Responsible Party:	Children's Hospital Boston ( Dr. Mary Ellen McCann )
Study ID Numbers:	06-07-0320
Study First Received:	September 18, 2008
Last Updated:	February 3, 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

Keywords provided by Children's Hospital Boston:

Infants
scheduled
unilateral
bilateral
repair

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Apnea
Hernia
Hernia, Abdominal
Central Nervous System Depressants

Anesthetics
Bupivacaine
Hernia, Inguinal
Anesthetics, Local
Sevoflurane

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009