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

This study is ongoing, but not recruiting participants.
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):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00756600
First received: September 18, 2008
Last updated: December 5, 2013
Last verified: December 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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: 720
Study Start Date: October 2006
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Show 30 Study Locations
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)
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:
Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00756600     History of Changes
Other Study ID Numbers: 06-07-0320
Study First Received: September 18, 2008
Last Updated: December 5, 2013
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

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014