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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00756600
Recruitment Status : Active, not recruiting
First Posted : September 22, 2008
Last Update Posted : November 3, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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. 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 or disease Intervention/treatment Phase
Inguinal Hernia Drug: Regional Anesthesia Drug: General Anesthesia Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2006
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 chronological age ]

Secondary Outcome Measures :
  1. Bayley neurodevelopmental scale. Also, frequency and characteristics of apnea in the post-operative period. [ Time Frame: At 2 years corrected age. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756600


  Show 30 Study Locations
Sponsors and Collaborators
Boston Children’s Hospital
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Ellen McCann, MD, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00756600     History of Changes
Other Study ID Numbers: 06-07-0320
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: February 2016

Keywords provided by Mary Ellen McCann, Boston Children's Hospital:
Infants
scheduled
unilateral
bilateral
repair

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