NCT00756600: GAS

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

Completed Phase 4 Results posted Last updated 29 April 2020

What this trial tests

Phase 4 trial testing Regional Anesthesia in Inguinal Hernia in 643 participants. Completed in 30 June 2018.

Timeline

23 October 2006

Primary endpoint
30 June 2018

30 June 2018

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	643
Start date	23 October 2006
Primary completion	30 June 2018
Estimated completion	30 June 2018
Sites	30 locations across Italy, New Zealand, Netherlands, United Kingdom, Canada, Australia, United States

Drugs / interventions tested

• Regional Anesthesia — full drug profile →
• General Anesthesia — full drug profile →

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

Boston Children's Hospital

Who can join

Under 60 Weeks, any sex, with Inguinal Hernia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Full Scale IQ Score Primary · At 5 years chronological age

The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability. Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the rese

Group	Value	95% CI
Regional Anesthesia	100.5	± 14.3
General Anesthesia	100.1	± 15.3

Verbal IQ Secondary · At 5 years corrected age.

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ Minimum possible score:45 Maximum possible score:145 A higher score indicates higher verbal IQ (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Group	Value	95% CI
Regional Anesthesia	101.8	± 14.7
General Anesthesia	100.9	± 15.4

Performance IQ Secondary · At 5 years corrected age

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ Minimum possible score:45 Maximum possible score:145 A higher score indicates a higher performance IQ (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Group	Value	95% CI
Regional Anesthesia	100.7	± 15.2
General Anesthesia	101.2	± 15.9

Processing Speed Quotient Secondary · At 5 years corrected age

Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient Minimum possible score:45 Maximum possible score:145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.

Group	Value	95% CI
Regional Anesthesia	95.8	± 14.5
General Anesthesia	96.3	± 15.4

Sentence Repetition Scaled Score Secondary · At 5 years chronological age

Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	9.7	± 2.9
General Anesthesia	9.7	± 2.8

Auditory Attention Combined Scaled Score Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	9.0	± 2.7
General Anesthesia	9.3	± 3.0

Statue Scaled Score Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	8.8	± 3.5
General Anesthesia	8.6	± 3.6

Inhibition Combined Scaled Score Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	8.3	± 3.1
General Anesthesia	8.9	± 3.0

Word Generation Scaled Score Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	9.4	± 3.4
General Anesthesia	9.3	± 3.3

Affect Recognition Scaled Score Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	10.6	± 2.8
General Anesthesia	10.4	± 3.2

Memory for Names and Memory for Names Delay Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	8.1	± 3.2
General Anesthesia	8.1	± 3.2

Theory of Mind Scaled Score Secondary · At 5 years corrected age

Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.

Group	Value	95% CI
Regional Anesthesia	9.8	± 2.9
General Anesthesia	9.3	± 3.0

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial.
   Davidson AJ, Disma N, de Graaff JC, Withington DE, et al · · 2016 · cited 594× · PMID 26507180 · DOI 10.1016/s0140-6736(15)00608-x
2. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial.
   McCann ME, de Graaff JC, Dorris L, Disma N, et al · · 2019 · cited 451× · PMID 30782342 · DOI 10.1016/s0140-6736(18)32485-1
3. Are anaesthetics toxic to the brain?
   Hudson AE, Hemmings HC. · · 2011 · cited 114× · PMID 21616941 · DOI 10.1093/bja/aer122
4. Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.
   Davidson AJ, Morton NS, Arnup SJ, de Graaff JC, et al · · 2015 · cited 109× · PMID 26001033 · DOI 10.1097/aln.0000000000000709
5. Differences in Blood Pressure in Infants After General Anesthesia Compared to Awake Regional Anesthesia (GAS Study-A Prospective Randomized Trial).
   McCann ME, Withington DE, Arnup SJ, Davidson AJ, et al · · 2017 · cited 65× · PMID 28489641 · DOI 10.1213/ane.0000000000001870
6. Predictors of Failure of Awake Regional Anesthesia for Neonatal Hernia Repair: Data from the General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes.
   Frawley G, Bell G, Disma N, Withington DE, et al · · 2015 · cited 40× · PMID 26001028 · DOI 10.1097/aln.0000000000000708
7. Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency.
   Dal-Ré R, Moher D, Gluud C, Treweek S, et al · · 2011 · cited 14× · PMID 22215987 · DOI 10.1371/journal.pmed.1001149
8. Adverse effect of inhalational anesthetics on the developing brain.
   Wang M, Zhang JH, Applegate RL. · · 2014 · cited 13× · PMID 24528992 · DOI 10.1186/2045-9912-4-2